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Multiple Treatment Session Study to Assess GSK2398852 Administered Following and Along With GSK2315698

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03044353
Recruitment Status : Terminated (Change in benefit/risk profile)
First Posted : February 7, 2017
Results First Posted : October 16, 2019
Last Update Posted : October 16, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Amyloidosis
Interventions Drug: GSK2315698 (CPHPC)
Biological: GSK2398852 (anti-SAP mAb)
Enrollment 7
Recruitment Details This was an open label, non-randomized, monthly repeat anti-serum amyloid p component (anti-SAP) treatment study in systemic amyloidosis participants with cardiac dysfunction caused by cardiac amyloidosis.
Pre-assignment Details Twelve participants were screened; seven were enrolled in to study (six were enrolled in Group 1 and one in Group 2). No participant was enrolled in Group 3. The study was terminated by sponsor due to a change in the benefit:risk profile of GSK2315698+GSK2398852 (anti-SAP treatment).
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants Group 3: Newly Diagnosed Mayo Stage II/IIIa AL Participants
Hide Arm/Group Description Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb. Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb. Newly diagnosed Mayo stage II/IIIa AL participants who attained a free light chain CR during the first 3 cycles of first-line chemotherapy where the first cycle was cyclophosphamide, bortezomib, dexamethasone (CyBorD) were planned to be included. Participants were planned to receive 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants were planned to receive CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were planned to administer IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was planned to be 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was planned to be administered as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Period Title: Overall Study
Started 6 1 0 [1]
Completed 6 0 0
Not Completed 0 1 0
Reason Not Completed
Adverse Event             0             1             0
[1]
No participant was enrolled in Group-3 due to early termination of the study.
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants Group 3: Newly Diagnosed Mayo Stage II/IIIa AL Participants Total
Hide Arm/Group Description Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb. Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb. Newly diagnosed Mayo stage II/IIIa AL participants who attained a free light chain CR during the first 3 cycles of first-line chemotherapy where the first cycle was cyclophosphamide, bortezomib, dexamethasone (CyBorD) were planned to be included. Participants were planned to receive 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants were planned to receive CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were planned to administer IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was planned to be 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was planned to be administered as SC injection for 11 days from the day of first dose of anti-SAP mAb. Total of all reporting groups
Overall Number of Baseline Participants 6 1 0 7
Hide Baseline Analysis Population Description
No participant was enrolled in "Group 3: Newly diagnosed Mayo stage II/IIIa AL participant" due to early termination of the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 1 participants 0 participants 7 participants
74.3  (3.27) 67.0 [1]   (NA) 73.3  (4.07)
[1]
Standard deviation could not be calculated due to insufficient number of participants (N=1).
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 1 participants 0 participants 7 participants
Female
0
   0.0%
0
   0.0%
0
0
   0.0%
Male
6
 100.0%
1
 100.0%
0
7
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 6 participants 1 participants 0 participants 7 participants
White/Caucasian/European Heritage
6
 100.0%
1
 100.0%
0
7
 100.0%
1.Primary Outcome
Title Change From Baseline in Left Ventricular (LV) Mass Over Time up to 8-week Follow-up
Hide Description Left ventricular mass was measured by Cardiac Magnetic Resonance (CMR) imaging to assess reduction in cardiac amyloid load after repeated administration of anti-SAP treatment. Each CMR imaging session took approximately 45-60 minutes, with a maximum scan time inside of the scanner of 90 minutes. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. Safety Population comprised of all participants who received at least one dose of study treatment (any dose of CPHPC [GSK2315698] or anti-SAP mAb [GSK2398852]).
Time Frame Baseline (Day -1) and Session 2 Day 24, Session 3 Day 24, Session 4 Day 24, Session 5 Day 24, 8 Weeks Follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 6 1
Mean (Standard Deviation)
Unit of Measure: Grams
Session 2, Day 24, n=6,0 Number Analyzed 6 participants 0 participants
2.505  (19.9174)
Session 3, Day 24, n=6,0 Number Analyzed 6 participants 0 participants
4.175  (22.9366)
Session 4, Day 24, n=5,0 Number Analyzed 5 participants 0 participants
9.194  (14.4271)
Session 5, Day 24, n=4,0 Number Analyzed 4 participants 0 participants
7.955  (19.4341)
8 Weeks Follow up, n=6,1 Number Analyzed 6 participants 1 participants
0.977  (12.1795) -32.420 [1]   (NA)
[1]
Standard deviation could not be calculated as only one participant was analyzed.
2.Primary Outcome
Title Number of Participants With Any On-treatment Adverse Events (AEs)
Hide Description AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Number of participants with any on-treatment AEs are presented.
Time Frame Up to 56 days after the last dosing session (up to 265 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 6 1
Measure Type: Count of Participants
Unit of Measure: Participants
6
 100.0%
1
 100.0%
3.Primary Outcome
Title Number of Participants With Any Serious Adverse Events (SAEs)
Hide Description AE is any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, events associated with liver injury and impaired liver function, or any other situation according to medical or scientific judgment were categorized as SAE. Number of participants with any SAEs during study are presented.
Time Frame Up to the end of study (Up to 369 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 6 1
Measure Type: Count of Participants
Unit of Measure: Participants
2
  33.3%
1
 100.0%
4.Primary Outcome
Title Number of Participants With Abnormal Hematology Values
Hide Description Blood samples were collected for assessment of hematology parameters, which included platelet count, hemoglobin, hematocrit, erythrocytes, reticulocyte count, Mean corpuscular volume (MCV), Mean corpuscular hemoglobin (MCH), Mean corpuscular hemoglobin concentration (MCHC), neutrophils, lymphocytes, monocytes, eosinophils, leukocytes and basophils. Abnormal laboratory results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.
Time Frame Up to the end of study (Up to 369 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 6 1
Measure Type: Count of Participants
Unit of Measure: Participants
Basophils, high
2
  33.3%
0
   0.0%
Basophils, normal
4
  66.7%
1
 100.0%
Basophils, low
0
   0.0%
0
   0.0%
Eosinophils, high
3
  50.0%
0
   0.0%
Eosinophils, normal
3
  50.0%
1
 100.0%
Eosinophils, low
0
   0.0%
0
   0.0%
Hematocrit, high
0
   0.0%
0
   0.0%
Hematocrit, normal
1
  16.7%
0
   0.0%
Hematocrit, low
5
  83.3%
1
 100.0%
Hemoglobin, high
0
   0.0%
0
   0.0%
Hemoglobin, normal
0
   0.0%
0
   0.0%
Hemoglobin, low
6
 100.0%
1
 100.0%
Lymphocytes, high
1
  16.7%
0
   0.0%
Lymphocytes, normal
0
   0.0%
0
   0.0%
Lymphocytes, low
6
 100.0%
1
 100.0%
MCH, high
1
  16.7%
0
   0.0%
MCH, normal
3
  50.0%
1
 100.0%
MCH, low
3
  50.0%
0
   0.0%
MCHC, high
3
  50.0%
0
   0.0%
MCHC, normal
1
  16.7%
1
 100.0%
MCHC, low
2
  33.3%
0
   0.0%
MCV, high
1
  16.7%
0
   0.0%
MCV, normal
4
  66.7%
1
 100.0%
MCV, low
2
  33.3%
0
   0.0%
Monocytes, high
2
  33.3%
1
 100.0%
Monocytes, normal
4
  66.7%
0
   0.0%
Monocytes, low
0
   0.0%
0
   0.0%
Neutrophils, high
5
  83.3%
1
 100.0%
Neutrophils, normal
0
   0.0%
0
   0.0%
Neutrophils, low
4
  66.7%
0
   0.0%
Platelet count, high
1
  16.7%
0
   0.0%
Platelet count, normal
3
  50.0%
0
   0.0%
Platelet count, low
2
  33.3%
1
 100.0%
Erythrocytes, high
0
   0.0%
0
   0.0%
Erythrocytes, normal
0
   0.0%
0
   0.0%
Erythrocytes, low
6
 100.0%
1
 100.0%
Reticulocytes, high
1
  16.7%
0
   0.0%
Reticulocytes, normal
5
  83.3%
1
 100.0%
Reticulocytes, low
0
   0.0%
0
   0.0%
Leukocytes, high
2
  33.3%
1
 100.0%
Leukocytes, normal
3
  50.0%
0
   0.0%
Leukocytes, low
1
  16.7%
0
   0.0%
5.Primary Outcome
Title Number of Participants With Abnormal Clinical Chemistry Values
Hide Description Blood samples were collected for assessment of clinical chemistry parameters, which included aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), lactate dehydrogenase (LDH), urea, creatinine, glucose, chloride, creatinine kinase, potassium, sodium, calcium, total carbon dioxide (CO2), urate, total and direct bilirubin, total protein and albumin. Abnormal laboratory results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.
Time Frame Up to the end of study (Up to 369 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 6 1
Measure Type: Count of Participants
Unit of Measure: Participants
Glucose, high
6
 100.0%
1
 100.0%
Glucose, normal
0
   0.0%
0
   0.0%
Glucose, low
0
   0.0%
0
   0.0%
Albumin, high
0
   0.0%
0
   0.0%
Albumin, normal
2
  33.3%
1
 100.0%
Albumin, low
4
  66.7%
0
   0.0%
ALP, high
5
  83.3%
0
   0.0%
ALP, normal
1
  16.7%
1
 100.0%
ALP, low
0
   0.0%
0
   0.0%
ALT, high
2
  33.3%
1
 100.0%
ALT, normal
4
  66.7%
0
   0.0%
ALT, low
0
   0.0%
0
   0.0%
AST, high
4
  66.7%
1
 100.0%
AST, normal
2
  33.3%
0
   0.0%
AST, low
0
   0.0%
0
   0.0%
Direct Bilirubin, high
4
  66.7%
1
 100.0%
Direct Bilirubin, normal
2
  33.3%
0
   0.0%
Direct Bilirubin, low
0
   0.0%
0
   0.0%
Total Bilirubin, high
4
  66.7%
0
   0.0%
Total Bilirubin, normal
2
  33.3%
1
 100.0%
Total Bilirubin, low
0
   0.0%
0
   0.0%
Calcium, high
0
   0.0%
0
   0.0%
Calcium, normal
4
  66.7%
0
   0.0%
Calcium, low
2
  33.3%
1
 100.0%
Creatinine Kinase, high
1
  16.7%
0
   0.0%
Creatinine Kinase, normal
3
  50.0%
1
 100.0%
Creatinine Kinase, low
2
  33.3%
0
   0.0%
Chloride, high
0
   0.0%
0
   0.0%
Chloride, normal
1
  16.7%
0
   0.0%
Chloride, low
5
  83.3%
1
 100.0%
CO2, high
6
 100.0%
0
   0.0%
CO2, normal
0
   0.0%
1
 100.0%
CO2, low
4
  66.7%
0
   0.0%
Creatinine, high
4
  66.7%
0
   0.0%
Creatinine, normal
2
  33.3%
1
 100.0%
Creatinine, low
0
   0.0%
0
   0.0%
Potassium, high
2
  33.3%
0
   0.0%
Potassium, normal
3
  50.0%
1
 100.0%
Potassium, low
2
  33.3%
0
   0.0%
LDH, high
6
 100.0%
1
 100.0%
LDH, normal
0
   0.0%
0
   0.0%
LDH, low
0
   0.0%
0
   0.0%
Protein, high
0
   0.0%
0
   0.0%
Protein, normal
0
   0.0%
0
   0.0%
Protein, low
6
 100.0%
1
 100.0%
Sodium, high
1
  16.7%
0
   0.0%
Sodium, normal
5
  83.3%
1
 100.0%
Sodium, low
0
   0.0%
0
   0.0%
Urate, high
5
  83.3%
1
 100.0%
Urate, normal
1
  16.7%
0
   0.0%
Urate, low
0
   0.0%
0
   0.0%
Urea, high
6
 100.0%
1
 100.0%
Urea, normal
0
   0.0%
0
   0.0%
Urea, low
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Number of Participants With Abnormal Urinalysis Results
Hide Description Urine samples were collected to assess potential of hydrogen (pH), specific gravity, albumin excretion rate, creatinine excretion rate and protein excretion rate. Abnormal urinalysis results are categorized as high, low or normal with respect to their normal ranges. Data for worst case post Baseline is presented. Participants having both High and Low values from Normal Ranges at any post-baseline visits for any parameter was counted in both the High and Low categories.
Time Frame Up to the end of study (Up to 369 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 6 1
Measure Type: Count of Participants
Unit of Measure: Participants
pH, high, n=6,1 Number Analyzed 6 participants 1 participants
0
   0.0%
0
   0.0%
pH, normal, n=6,1 Number Analyzed 6 participants 1 participants
6
 100.0%
1
 100.0%
pH, low, n=6,1 Number Analyzed 6 participants 1 participants
0
   0.0%
0
   0.0%
Specific gravity, high, n=1,0 Number Analyzed 1 participants 0 participants
0
   0.0%
Specific gravity, normal, n=1,0 Number Analyzed 1 participants 0 participants
1
 100.0%
Specific gravity, low, n=1,0 Number Analyzed 1 participants 0 participants
0
   0.0%
Albumin excretion rate, high, n=6,1 Number Analyzed 6 participants 1 participants
0
   0.0%
0
   0.0%
Albumin excretion rate, normal, n=6,1 Number Analyzed 6 participants 1 participants
6
 100.0%
1
 100.0%
Albumin excretion rate, low, n=6,1 Number Analyzed 6 participants 1 participants
0
   0.0%
0
   0.0%
Creatinine excretion rate, high, n=6,1 Number Analyzed 6 participants 1 participants
1
  16.7%
0
   0.0%
Creatinine excretion rate, normal, n=6,1 Number Analyzed 6 participants 1 participants
1
  16.7%
1
 100.0%
Creatinine excretion rate, low, n=6,1 Number Analyzed 6 participants 1 participants
5
  83.3%
0
   0.0%
Protein excretion rate, high, n=6,1 Number Analyzed 6 participants 1 participants
4
  66.7%
1
 100.0%
Protein excretion rate, normal, n=6,1 Number Analyzed 6 participants 1 participants
2
  33.3%
0
   0.0%
Protein excretion rate, low, n=6,1 Number Analyzed 6 participants 1 participants
0
   0.0%
0
   0.0%
7.Primary Outcome
Title Number of Participants With Abnormal Urinalysis Results for Character Parameters
Hide Description Urine samples were collected to assess character parameters which included Cellular Casts, Erythrocytes, Glucose, Ketones, Leukocytes and Occult Blood. Number of participants with abnormal urinalysis results are presented. Data for worst case post Baseline is presented.
Time Frame Up to the end of study (Up to 369 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 6 1
Measure Type: Count of Participants
Unit of Measure: Participants
Cellular casts, n=5,1 Number Analyzed 5 participants 1 participants
0
   0.0%
0
   0.0%
Erythrocytes , n=6,1 Number Analyzed 6 participants 1 participants
6
 100.0%
1
 100.0%
Glucose, n=6,1 Number Analyzed 6 participants 1 participants
1
  16.7%
0
   0.0%
Ketones, n=6,1 Number Analyzed 6 participants 1 participants
0
   0.0%
0
   0.0%
Leukocytes, n=6,1 Number Analyzed 6 participants 1 participants
6
 100.0%
1
 100.0%
Occult blood, n=6,1 Number Analyzed 6 participants 1 participants
2
  33.3%
1
 100.0%
8.Primary Outcome
Title Number of Participants With Body Temperature Shifts From Baseline Relative to Potential Clinical Importance (PCI) Criteria
Hide Description Vital signs including body temperature was measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in body temperature from Baseline to worst case post Baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to PCI criteria. PCI criteria for body temperature was: high: >37.5 degree Celsius; low: not applicable.
Time Frame Up to the end of study (Up to 369 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 6 1
Measure Type: Count of Participants
Unit of Measure: Participants
To high
2
  33.3%
0
   0.0%
To normal/No change
4
  66.7%
1
 100.0%
To low
0
   0.0%
0
   0.0%
9.Primary Outcome
Title Number of Participants With Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Shifts From Baseline Relative to PCI Criteria
Hide Description Vital signs including SBP and DBP were measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in SBP and DBP from baseline to worst case post baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to PCI criteria. PCI criteria for SBP was: high: >180 millimeter of mercury (mmHg); low: <90 mmHg. PCI criteria for DBP was: high: >110 mmHg; low: <30 mmHg.
Time Frame Up to the end of study (Up to 369 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 6 1
Measure Type: Count of Participants
Unit of Measure: Participants
SBP, To high
0
   0.0%
0
   0.0%
SBP, To normal/No change
1
  16.7%
1
 100.0%
SBP, To low
5
  83.3%
0
   0.0%
DBP, To high
0
   0.0%
0
   0.0%
DBP, To normal/No change
6
 100.0%
1
 100.0%
DBP, To low
0
   0.0%
0
   0.0%
10.Primary Outcome
Title Number of Participants With Pulse Rate Shifts From Baseline Relative to PCI Criteria
Hide Description Vital signs including pulse rate were measured after participants rested in semi-supine position for at least 5 minutes. Number of participants with shifts in pulse rate from baseline to worst case post baseline relative to PCI criteria have been presented. PCI results were categorized as to high, to low and to normal/no change with reference to its PCI criteria. PCI criteria for pulse rate was: high: >140 beats per minute (bpm); low: <35 bpm.
Time Frame Up to the end of study (Up to 369 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 6 1
Measure Type: Count of Participants
Unit of Measure: Participants
To high
0
   0.0%
0
   0.0%
To normal/No change
6
 100.0%
1
 100.0%
To low
0
   0.0%
0
   0.0%
11.Primary Outcome
Title Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Hide Description Twelve-lead ECGs were performed during the study using an automated ECG machine. The number of participants with worst case post-Baseline abnormal ECG findings were reported and categorized as abnormal-clinically significant and abnormal-not clinically significant.
Time Frame Up to the end of study (Up to 369 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 6 1
Measure Type: Count of Participants
Unit of Measure: Participants
Abnormal-Clinically significant
0
   0.0%
0
   0.0%
Abnormal-Not Clinically significant
6
 100.0%
1
 100.0%
12.Primary Outcome
Title Number of Participants With Abnormalities During Cardiac Monitoring
Hide Description Lead II telemetry and cardiac monitoring devices were used for electrical cardiac monitoring during the study. The number of participants with worst case post-Baseline abnormalities during cardiac monitoring as per investigator's assessment have been reported and categorized as Abnormal-clinically significant and Abnormal-not clinically significant.
Time Frame Up to the end of study (Up to 369 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time point was analyzed.
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 5 1
Measure Type: Count of Participants
Unit of Measure: Participants
Abnormal-Clinically significant
2
  40.0%
0
   0.0%
Abnormal-Not Clinically significant
3
  60.0%
1
 100.0%
13.Primary Outcome
Title Number of Participants for Which Unscheduled Echocardiography (ECHO) Was Performed for Safety Reasons
Hide Description Echocardiography was performed by a qualified echocardiographer or cardiologist during the study. Number of participants with unscheduled echocardiograms performed for safety reasons have been presented.
Time Frame Up to the end of study (Up to 369 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time point was analyzed.
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 2 0
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
14.Primary Outcome
Title Number of Participants With Skin Rashes
Hide Description Skin rash was an event of special interest. Only Rashes that were associated with study drug were categorised as Rash for Common Terminology Criteria for Adverse Events (CTCAE) and are presented. Number of participants with on-treatment skin rash AEs are presented.
Time Frame Up to 56 days after the last dosing session (up to 265 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 6 1
Measure Type: Count of Participants
Unit of Measure: Participants
4
  66.7%
0
   0.0%
15.Primary Outcome
Title Number of Participants With Skin Rashes Classified Using CTCAE
Hide Description Skin rash was an event of special interest. All the events of rashes were graded for their severity using CTCAE version 4.0 . Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life threatening, Grade 5: death. Higher the grade, more severe the symptoms. Only Rashes that were associated with study drug were categorised as Rash for CTCAE and are presented here. Number of participants with skin rashes classified by their maximum grade are presented.
Time Frame Up to 56 days after the last dosing session (up to 265 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time point was analyzed.
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 4 0
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 1
3
  75.0%
Grade 2
1
  25.0%
Grade 3
0
   0.0%
Grade 4
0
   0.0%
Grade 5
0
   0.0%
16.Secondary Outcome
Title Number of Participants With Abnormalities in Histopathological Examination of Skin Biopsies
Hide Description Skin biopsy samples were collected for histopathological examination only on any rash development (>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist. Number of participants with abnormalities in histopathological examination of skin biopsies are presented.
Time Frame Up to the end of study (Up to 369 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 6 1
Measure Type: Count of Participants
Unit of Measure: Participants
2
  33.3%
0
   0.0%
17.Secondary Outcome
Title Number of Participants With Abnormalities in Immunohistochemical Examination of Skin Biopsies
Hide Description Skin biopsy samples were collected for immunohistochemical examination only on any rash development (>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist. Number of participants with abnormalities in immunohistochemical examination of skin biopsies are presented.
Time Frame Up to the end of study (Up to 369 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 6 1
Measure Type: Count of Participants
Unit of Measure: Participants
2
  33.3%
0
   0.0%
18.Secondary Outcome
Title Number of Participants With Abnormalities in Histopathological Examination of Blood Biomarkers
Hide Description Blood samples were to be collected along with each skin biopsy sample for histopathological examination of blood biomarkers only on any rash development (>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist.
Time Frame Up to the end of study (Up to 369 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Data was not collected due to project termination.
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
19.Secondary Outcome
Title Number of Participants With Abnormalities in Immunohistochemical Examination of Blood Biomarkers
Hide Description Blood samples were to be collected along with each skin biopsy sample for immunohistochemical examination of blood biomarkers only on any rash development (>= Grade 1) as decided by clinical judgment of the Investigator and/or dermatologist.
Time Frame Up to the end of study (Up to 369 days)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Data was not collected due to project termination.
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
20.Secondary Outcome
Title Change From Baseline in Plasma Cytokines Over Time
Hide Description Blood samples were collected for assessment of plasma cytokines biomarkers which included Tumor Necrosis Factor (TNF), Interleukin 1 beta (IL-1 beta), IL-6, IL-10, Interferon gamma (INF gamma), IL-12, IL-13, IL-2, IL-4 and IL-8. Baseline was considered as the latest assessment prior to first administration of either study drug, i.e. CPHPC or anti-SAP mAb. Change from Baseline was calculated as post-dose visit value minus Baseline value. Absolute values below the lower limit of quantification (LLQ) were imputed with half the LLQ and those above the upper limit of quantification (ULQ) were imputed with the ULQ.
Time Frame Baseline (Day -1) and Session 1: Day 1 (predose, 1,3,6 hours), Day 2, Day 3 (predose, 1,3,6 hours), Day 4, Day 5; Session 2 to 6: Day -2, Day 1 (predose, 1,3,6 hours), Day 2, Day 3 (predose, 1,3,6 hours), Day 4, Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n= X in the category titles).
Arm/Group Title Group 1: Cardiac TTR Amyloidosis (ATTR-CM) Participants Group 2: Post-chemotherapy AL Amyloidosis Participants
Hide Arm/Group Description:
Cardiac transthyretin (TTR) amyloidosis (transthyretin amyloid cardiomyopathy [ATTR-CM]) participants with mutant genotypes primarily associated with familial amyloidotic cardiomyopathy (FAC) and wild-type TTR were included. Participants received 6 anti-SAP treatments, consisting of carboxy pyrrolidine hexanoyl pyrrolidine carboxylate (CPHPC) followed by anti-SAP monoclonal antibody (mAb) at monthly intervals. During each anti-SAP treatment, participants received CPHPC intravenous (IV) infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered intravenous infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 milligrams (mg) (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered as subcutaneous (SC) injection for 11 days from the day of first dose of anti-SAP mAb.
Immunoglobin light chain amyloidosis (AL) participants who attained either a very good partial response (VGPR), or complete response (CR), to systemic chemotherapy (including autologous stem cell transplantation) were included. Participants received 6 anti-SAP treatments, consisting of CPHPC followed by anti-SAP mAb at monthly intervals. During each anti-SAP treatment, participants received CPHPC IV infusion once daily for up to 72 hours. After 72 hours of CPHPC administration, participants were administered IV infusion of anti-SAP mAb over 6-8 hours each on Days 1 and 3. The starting dose level of anti-SAP mAb was 600 mg (divided into 2 infusions of 300 mg). In each treatment session, CPHPC was administered by as SC injection for 11 days from the day of first dose of anti-SAP mAb.
Overall Number of Participants Analyzed 6 1
Mean (Standard Deviation)
Unit of Measure: Nanograms per liter (ng/L)
IL-1 beta, Session 1, Day 1, predose, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-1 beta, Session 1, Day 1, 1 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-1 beta, Session 1, Day 1, 3 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-1 beta, Session 1, Day 1, 6 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-1 beta, Session 1, Day 2, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-1 beta, Session 1, Day 3, predose, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-1 beta, Session 1, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 1, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 1, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 1, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 1, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 2, Day -2, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 2, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 2, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 2, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 2, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 2, Day 2, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 2, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 2, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 2, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 2, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 2, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 2, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 3, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 3, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 3, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 3, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 3, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 3, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 3, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 3, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.293  (0.7185)
IL-1 beta, Session 3, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 3, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 3, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 3, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 4, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 4, Day 1, predose, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 4, Day 1, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 4, Day 1, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 4, Day 1, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 4, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 4, Day 3, predose, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 4, Day 3, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 4, Day 3, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 4, Day 3, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 4, Day 4, n=5,0 Number Analyzed 5 participants 0 participants
0.504  (1.1270)
IL-1 beta, Session 4, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 5, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 5, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 5, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 5, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 5, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 5, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 5, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 5, Day 3, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 5, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 5, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 5, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 5, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 6, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 6, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 6, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 6, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 6, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 6, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 6, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 6, Day 3, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 6, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 6, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 6, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-1 beta, Session 6, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-6, Session 1, Day 1, predose, n=6,1 Number Analyzed 6 participants 1 participants
0.275  (0.4711) 0.000 [1]   (NA)
IL-6, Session 1, Day 1, 1 hour, n=6,1 Number Analyzed 6 participants 1 participants
-0.080  (0.7723) 0.000 [1]   (NA)
IL-6, Session 1, Day 1, 3 hour, n=6,1 Number Analyzed 6 participants 1 participants
-0.727  (1.2035) 0.000 [1]   (NA)
IL-6, Session 1, Day 1, 6 hour, n=6,1 Number Analyzed 6 participants 1 participants
-1.077  (1.2511) 2.880 [1]   (NA)
IL-6, Session 1, Day 2, n=6,1 Number Analyzed 6 participants 1 participants
6.278  (6.3567) 29.030 [1]   (NA)
IL-6, Session 1, Day 3, predose, n=6,1 Number Analyzed 6 participants 1 participants
7.688  (8.8639) 16.980 [1]   (NA)
IL-6, Session 1, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
6.857  (10.5934)
IL-6, Session 1, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.827  (3.5790)
IL-6, Session 1, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.932  (5.5637)
IL-6, Session 1, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
5.453  (3.6039)
IL-6, Session 1, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
3.245  (3.3934)
IL-6, Session 2, Day -2, n=6,0 Number Analyzed 6 participants 0 participants
0.393  (0.5250)
IL-6, Session 2, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.632  (1.2026)
IL-6, Session 2, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.025  (0.7117)
IL-6, Session 2, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
-0.860  (1.0909)
IL-6, Session 2, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
-0.282  (1.7148)
IL-6, Session 2, Day 2, n=6,0 Number Analyzed 6 participants 0 participants
21.590  (27.1214)
IL-6, Session 2, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
11.365  (11.4140)
IL-6, Session 2, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
7.517  (8.6084)
IL-6, Session 2, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
3.460  (5.0176)
IL-6, Session 2, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.723  (4.5392)
IL-6, Session 2, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
4.580  (5.9326)
IL-6, Session 2, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
6.395  (5.2800)
IL-6, Session 3, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
0.148  (0.8211)
IL-6, Session 3, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.782  (1.5023)
IL-6, Session 3, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.268  (1.4865)
IL-6, Session 3, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.062  (2.5899)
IL-6, Session 3, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
-0.918  (1.2591)
IL-6, Session 3, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
17.608  (29.2558)
IL-6, Session 3, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
11.872  (8.7413)
IL-6, Session 3, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
5.835  (3.8271)
IL-6, Session 3, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
1.742  (1.9174)
IL-6, Session 3, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.063  (2.2072)
IL-6, Session 3, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
4.667  (6.9875)
IL-6, Session 3, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
5.570  (2.6004)
IL-6, Session 4, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
0.892  (0.8423)
IL-6, Session 4, Day 1, predose, n=5,0 Number Analyzed 5 participants 0 participants
1.486  (0.8702)
IL-6, Session 4, Day 1, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.926  (0.7103)
IL-6, Session 4, Day 1, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
-0.026  (0.1599)
IL-6, Session 4, Day 1, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
-1.028  (1.3685)
IL-6, Session 4, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
5.720  (11.3851)
IL-6, Session 4, Day 3, predose, n=5,0 Number Analyzed 5 participants 0 participants
10.924  (6.5370)
IL-6, Session 4, Day 3, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
4.486  (2.0420)
IL-6, Session 4, Day 3, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
1.446  (1.5368)
IL-6, Session 4, Day 3, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
-0.116  (1.7948)
IL-6, Session 4, Day 4, n=5,0 Number Analyzed 5 participants 0 participants
5.756  (6.8645)
IL-6, Session 4, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
4.388  (3.7765)
IL-6, Session 5, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
0.027  (0.8164)
IL-6, Session 5, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.865  (0.9927)
IL-6, Session 5, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
-0.007  (1.3219)
IL-6, Session 5, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
-0.423  (1.5816)
IL-6, Session 5, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
-1.213  (1.5189)
IL-6, Session 5, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
0.905  (4.0920)
IL-6, Session 5, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
7.323  (4.8265)
IL-6, Session 5, Day 3, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
4.240  (3.6214)
IL-6, Session 5, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
-0.125  (0.7543)
IL-6, Session 5, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
-1.390  (1.3301)
IL-6, Session 5, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
3.598  (5.7476)
IL-6, Session 5, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
6.533  (2.6812)
IL-6, Session 6, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
1.383  (1.8535)
IL-6, Session 6, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.565  (1.4007)
IL-6, Session 6, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.077  (1.1200)
IL-6, Session 6, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
-0.413  (1.4416)
IL-6, Session 6, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
-1.165  (0.9786)
IL-6, Session 6, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
0.932  (4.0340)
IL-6, Session 6, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
15.008  (13.0010)
IL-6, Session 6, Day 3, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
10.083  (9.2076)
IL-6, Session 6, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
1.435  (1.7505)
IL-6, Session 6, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
-1.005  (1.3522)
IL-6, Session 6, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
1.740  (3.2649)
IL-6, Session 6, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
7.190  (3.8811)
IL-10, Session 1, Day 1, predose, n=6,1 Number Analyzed 6 participants 1 participants
-0.067  (0.1633) 0.000 [1]   (NA)
IL-10, Session 1, Day 1, 1 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.105  (0.1663) 8.580 [1]   (NA)
IL-10, Session 1, Day 1, 3 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.763  (0.4804) 5.260 [1]   (NA)
IL-10, Session 1, Day 1, 6 hour, n=6,1 Number Analyzed 6 participants 1 participants
1.710  (1.4719) 6.020 [1]   (NA)
IL-10, Session 1, Day 2, n=6,1 Number Analyzed 6 participants 1 participants
-0.005  (0.2436) 1.150 [1]   (NA)
IL-10, Session 1, Day 3, predose, n=6,1 Number Analyzed 6 participants 1 participants
0.040  (0.3347) 1.280 [1]   (NA)
IL-10, Session 1, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.670  (1.0153)
IL-10, Session 1, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.065  (0.3896)
IL-10, Session 1, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.002  (0.0041)
IL-10, Session 1, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
-0.067  (0.1633)
IL-10, Session 1, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
-0.067  (0.1633)
IL-10, Session 2, Day -2, n=6,0 Number Analyzed 6 participants 0 participants
-0.067  (0.1633)
IL-10, Session 2, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.002  (0.0041)
IL-10, Session 2, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.612  (0.8293)
IL-10, Session 2, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
1.132  (1.1748)
IL-10, Session 2, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.785  (0.5189)
IL-10, Session 2, Day 2, n=6,0 Number Analyzed 6 participants 0 participants
0.012  (0.2757)
IL-10, Session 2, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.233  (0.5618)
IL-10, Session 2, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.775  (1.1274)
IL-10, Session 2, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.782  (0.8451)
IL-10, Session 2, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.015  (0.0367)
IL-10, Session 2, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
-0.005  (0.0122)
IL-10, Session 2, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
0.110  (0.2122)
IL-10, Session 3, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
0.032  (0.3422)
IL-10, Session 3, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
-0.067  (0.1633)
IL-10, Session 3, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.228  (0.2328)
IL-10, Session 3, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
1.185  (1.1559)
IL-10, Session 3, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.495  (0.6641)
IL-10, Session 3, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
-0.080  (0.1789)
IL-10, Session 3, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
-0.067  (0.1633)
IL-10, Session 3, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.450  (0.6048)
IL-10, Session 3, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.322  (0.5322)
IL-10, Session 3, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.092  (0.1542)
IL-10, Session 3, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
-0.067  (0.1633)
IL-10, Session 3, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
-0.067  (0.1633)
IL-10, Session 4, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
-0.080  (0.1789)
IL-10, Session 4, Day 1, predose, n=5,0 Number Analyzed 5 participants 0 participants
-0.080  (0.1789)
IL-10, Session 4, Day 1, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.758  (1.4466)
IL-10, Session 4, Day 1, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
3.868  (6.3123)
IL-10, Session 4, Day 1, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.868  (0.9281)
IL-10, Session 4, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
-0.080  (0.1789)
IL-10, Session 4, Day 3, predose, n=5,0 Number Analyzed 5 participants 0 participants
0.022  (0.0492)
IL-10, Session 4, Day 3, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.808  (1.0592)
IL-10, Session 4, Day 3, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.598  (0.6549)
IL-10, Session 4, Day 3, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.184  (0.4284)
IL-10, Session 4, Day 4, n=5,0 Number Analyzed 5 participants 0 participants
-0.080  (0.1789)
IL-10, Session 4, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
-0.100  (0.2000)
IL-10, Session 5, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
-0.100  (0.2000)
IL-10, Session 5, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
-0.100  (0.2000)
IL-10, Session 5, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
2.485  (4.8507)
IL-10, Session 5, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
3.828  (6.5828)
IL-10, Session 5, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
1.120  (1.5607)
IL-10, Session 5, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
-0.100  (0.2000)
IL-10, Session 5, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.393  (0.4774)
IL-10, Session 5, Day 3, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.950  (0.9330)
IL-10, Session 5, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
1.060  (0.9783)
IL-10, Session 5, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.663  (0.6663)
IL-10, Session 5, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
0.210  (0.4267)
IL-10, Session 5, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.025  (0.0500)
IL-10, Session 6, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
-0.100  (0.2000)
IL-10, Session 6, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
-0.100  (0.2000)
IL-10, Session 6, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.333  (0.9506)
IL-10, Session 6, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
1.738  (2.5365)
IL-10, Session 6, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
1.418  (1.7245)
IL-10, Session 6, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
-0.100  (0.2000)
IL-10, Session 6, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.015  (0.0300)
IL-10, Session 6, Day 3, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.753  (1.4004)
IL-10, Session 6, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.675  (1.1466)
IL-10, Session 6, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.220  (0.2723)
IL-10, Session 6, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
-0.100  (0.2000)
IL-10, Session 6, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.023  (0.0450)
TNF, Session 1, Day 1, predose, n=6,1 Number Analyzed 6 participants 1 participants
0.055  (0.4378) 0.320 [1]   (NA)
TNF, Session 1, Day 1, 1 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.007  (0.7159) 0.100 [1]   (NA)
TNF, Session 1, Day 1, 3 hour, n=6,1 Number Analyzed 6 participants 1 participants
-0.180  (0.7430) 0.880 [1]   (NA)
TNF, Session 1, Day 1, 6 hour, n=6,1 Number Analyzed 6 participants 1 participants
-0.132  (0.8145) 2.300 [1]   (NA)
TNF, Session 1, Day 2, n=6,1 Number Analyzed 6 participants 1 participants
1.920  (1.5379) 5.130 [1]   (NA)
TNF, Session 1, Day 3, predose, n=6,1 Number Analyzed 6 participants 1 participants
1.453  (1.3405) 3.010 [1]   (NA)
TNF, Session 1, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
1.240  (0.9968)
TNF, Session 1, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.797  (1.0229)
TNF, Session 1, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.460  (0.9373)
TNF, Session 1, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
1.088  (1.2874)
TNF, Session 1, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
1.577  (1.5915)
TNF, Session 2, Day -2, n=6,0 Number Analyzed 6 participants 0 participants
0.167  (0.9735)
TNF, Session 2, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.233  (0.8351)
TNF, Session 2, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.133  (1.0259)
TNF, Session 2, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.015  (1.0940)
TNF, Session 2, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
-0.100  (1.2625)
TNF, Session 2, Day 2, n=6,0 Number Analyzed 6 participants 0 participants
1.523  (1.6646)
TNF, Session 2, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
2.143  (1.5642)
TNF, Session 2, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
1.682  (1.3855)
TNF, Session 2, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
1.133  (0.9970)
TNF, Session 2, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.503  (1.0718)
TNF, Session 2, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
1.397  (2.1712)
TNF, Session 2, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
1.968  (1.4560)
TNF, Session 3, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
0.098  (1.2163)
TNF, Session 3, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.497  (0.9650)
TNF, Session 3, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
-0.297  (0.9572)
TNF, Session 3, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
-0.198  (0.9246)
TNF, Session 3, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
-0.167  (1.2317)
TNF, Session 3, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
0.446  (1.1212)
TNF, Session 3, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
1.267  (1.1583)
TNF, Session 3, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.513  (1.1234)
TNF, Session 3, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.128  (1.0706)
TNF, Session 3, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.233  (1.2605)
TNF, Session 3, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
0.585  (1.6017)
TNF, Session 3, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
0.997  (1.3819)
TNF, Session 4, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
-0.208  (0.5949)
TNF, Session 4, Day 1, predose, n=5,0 Number Analyzed 5 participants 0 participants
-0.214  (0.8527)
TNF, Session 4, Day 1, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.160  (1.5494)
TNF, Session 4, Day 1, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.218  (1.5011)
TNF, Session 4, Day 1, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
-0.412  (1.1373)
TNF, Session 4, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
-0.122  (0.6977)
TNF, Session 4, Day 3, predose, n=5,0 Number Analyzed 5 participants 0 participants
0.606  (0.5265)
TNF, Session 4, Day 3, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.100  (0.5074)
TNF, Session 4, Day 3, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.098  (0.7172)
TNF, Session 4, Day 3, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
-0.702  (0.5368)
TNF, Session 4, Day 4, n=5,0 Number Analyzed 5 participants 0 participants
-0.270  (0.7576)
TNF, Session 4, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.095  (0.4456)
TNF, Session 5, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
-0.350  (0.5814)
TNF, Session 5, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
-0.320  (0.6703)
TNF, Session 5, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
-0.130  (1.2227)
TNF, Session 5, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
-0.055  (1.0728)
TNF, Session 5, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
-0.513  (1.1003)
TNF, Session 5, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
-0.498  (0.9752)
TNF, Session 5, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.147  (0.8951)
TNF, Session 5, Day 3, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
-0.188  (0.7406)
TNF, Session 5, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
-0.378  (0.9306)
TNF, Session 5, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
-0.630  (0.7857)
TNF, Session 5, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
-0.100  (1.0725)
TNF, Session 5, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.168  (0.3909)
TNF, Session 6, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
-0.428  (1.3664)
TNF, Session 6, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
-0.238  (1.3158)
TNF, Session 6, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
-0.303  (1.3853)
TNF, Session 6, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
-0.145  (1.8684)
TNF, Session 6, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
-0.500  (1.4020)
TNF, Session 6, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
-0.000  (1.3253)
TNF, Session 6, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.278  (1.9987)
TNF, Session 6, Day 3, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
-0.195  (1.6007)
TNF, Session 6, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
-0.385  (1.4669)
TNF, Session 6, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
-0.585  (1.3026)
TNF, Session 6, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
-0.368  (1.1280)
TNF, Session 6, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.322  (1.2795)
INF gamma, Session 1, Day 1, predose, n=6,1 Number Analyzed 6 participants 1 participants
0.075  (1.6224) 1.860 [1]   (NA)
INF gamma, Session 1, Day 1, 1 hour, n=6,1 Number Analyzed 6 participants 1 participants
-1.373  (2.1255) 0.000 [1]   (NA)
INF gamma, Session 1, Day 1, 3 hour, n=6,1 Number Analyzed 6 participants 1 participants
-3.298  (3.1409) 0.000 [1]   (NA)
INF gamma, Session 1, Day 1, 6 hour, n=6,1 Number Analyzed 6 participants 1 participants
-3.298  (3.1409) 0.000 [1]   (NA)
INF gamma, Session 1, Day 2, n=6,1 Number Analyzed 6 participants 1 participants
1.713  (7.5955) 1.930 [1]   (NA)
INF gamma, Session 1, Day 3, predose, n=6,1 Number Analyzed 6 participants 1 participants
17.122  (27.3980) 0.000 [1]   (NA)
INF gamma, Session 1, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
12.118  (22.0807)
INF gamma, Session 1, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
7.150  (18.4949)
INF gamma, Session 1, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.538  (8.5114)
INF gamma, Session 1, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
3.242  (12.2847)
INF gamma, Session 1, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
19.502  (38.3215)
INF gamma, Session 2, Day -2, n=6,0 Number Analyzed 6 participants 0 participants
-1.045  (3.4175)
INF gamma, Session 2, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.452  (3.5018)
INF gamma, Session 2, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.145  (3.2180)
INF gamma, Session 2, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
-1.833  (1.3991)
INF gamma, Session 2, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
-3.072  (2.6378)
INF gamma, Session 2, Day 2, n=6,0 Number Analyzed 6 participants 0 participants
-2.660  (3.5043)
INF gamma, Session 2, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
-1.045  (2.2260)
INF gamma, Session 2, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
-1.580  (2.5672)
INF gamma, Session 2, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
-2.473  (2.5631)
INF gamma, Session 2, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
-3.298  (3.1409)
INF gamma, Session 2, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
-2.572  (3.4040)
INF gamma, Session 2, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
-1.993  (2.8977)
INF gamma, Session 3, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
-2.190  (3.9839)
INF gamma, Session 3, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
-1.035  (4.4739)
INF gamma, Session 3, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
-2.180  (3.8365)
INF gamma, Session 3, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
-3.298  (3.1409)
INF gamma, Session 3, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
-3.298  (3.1409)
INF gamma, Session 3, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
-2.936  (3.7855)
INF gamma, Session 3, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
-2.948  (2.3737)
INF gamma, Session 3, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
-3.298  (3.1409)
INF gamma, Session 3, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
-3.298  (3.1409)
INF gamma, Session 3, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
-3.298  (3.1409)
INF gamma, Session 3, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
-3.048  (3.1886)
INF gamma, Session 3, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
-2.752  (3.2989)
INF gamma, Session 4, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
0.298  (5.3631)
INF gamma, Session 4, Day 1, predose, n=5,0 Number Analyzed 5 participants 0 participants
-0.760  (4.2290)
INF gamma, Session 4, Day 1, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
-1.240  (4.3736)
INF gamma, Session 4, Day 1, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
-2.778  (3.9570)
INF gamma, Session 4, Day 1, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
-3.274  (3.5110)
INF gamma, Session 4, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
-3.274  (3.5110)
INF gamma, Session 4, Day 3, predose, n=5,0 Number Analyzed 5 participants 0 participants
-2.836  (2.6051)
INF gamma, Session 4, Day 3, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
-3.274  (3.5110)
INF gamma, Session 4, Day 3, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
-3.274  (3.5110)
INF gamma, Session 4, Day 3, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
-3.274  (3.5110)
INF gamma, Session 4, Day 4, n=5,0 Number Analyzed 5 participants 0 participants
-3.274  (3.5110)
INF gamma, Session 4, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
-2.910  (3.1667)
INF gamma, Session 5, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
-0.930  (3.5480)
INF gamma, Session 5, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
-1.328  (2.1878)
INF gamma, Session 5, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
-1.423  (1.9828)
INF gamma, Session 5, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
-2.725  (2.8230)
INF gamma, Session 5, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
-3.373  (4.0462)
INF gamma, Session 5, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
-3.373  (4.0462)
INF gamma, Session 5, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.753  (4.9155)
INF gamma, Session 5, Day 3, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.203  (4.5195)
INF gamma, Session 5, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
-1.388  (4.8505)
INF gamma, Session 5, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
-2.838  (4.4804)
INF gamma, Session 5, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
-1.653  (6.0355)
INF gamma, Session 5, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
-0.615  (2.9091)
INF gamma, Session 6, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
-2.625  (4.4662)
INF gamma, Session 6, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
-2.668  (4.4299)
INF gamma, Session 6, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
-2.823  (4.3091)
INF gamma, Session 6, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
-3.373  (4.0462)
INF gamma, Session 6, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
-3.373  (4.0462)
INF gamma, Session 6, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
-3.373  (4.0462)
INF gamma, Session 6, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
-1.988  (5.0857)
INF gamma, Session 6, Day 3, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
-3.018  (4.1848)
INF gamma, Session 6, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
-3.373  (4.0462)
INF gamma, Session 6, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
-3.373  (4.0462)
INF gamma, Session 6, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
-3.373  (4.0462)
INF gamma, Session 6, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
-3.373  (4.0462)
IL-12, Session 1, Day 1, predose, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-12, Session 1, Day 1, 1 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-12, Session 1, Day 1, 3 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-12, Session 1, Day 1, 6 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-12, Session 1, Day 2, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-12, Session 1, Day 3, predose, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-12, Session 1, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 1, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 1, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 1, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 1, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 2, Day -2, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 2, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 2, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 2, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 2, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 2, Day 2, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 2, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 2, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 2, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 2, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 2, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 2, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 3, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-12, Session 3, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 3, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 3, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 3, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 3, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-12, Session 3, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 3, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 3, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 3, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 3, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 3, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-12, Session 4, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-12, Session 4, Day 1, predose, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-12, Session 4, Day 1, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-12, Session 4, Day 1, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-12, Session 4, Day 1, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-12, Session 4, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-12, Session 4, Day 3, predose, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-12, Session 4, Day 3, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-12, Session 4, Day 3, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-12, Session 4, Day 3, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-12, Session 4, Day 4, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-12, Session 4, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 5, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 5, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 5, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 5, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 5, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 5, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 5, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 5, Day 3, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 5, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 5, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 5, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 5, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 6, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 6, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 6, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 6, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 6, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 6, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 6, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 6, Day 3, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 6, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 6, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 6, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-12, Session 6, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 1, Day 1, predose, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-13, Session 1, Day 1, 1 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-13, Session 1, Day 1, 3 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-13, Session 1, Day 1, 6 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-13, Session 1, Day 2, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-13, Session 1, Day 3, predose, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-13, Session 1, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 1, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 1, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 1, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 1, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 2, Day -2, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 2, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 2, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 2, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 2, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 2, Day 2, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 2, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 2, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 2, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 2, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 2, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 2, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 3, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-13, Session 3, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 3, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 3, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 3, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 3, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-13, Session 3, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.333  (0.8165)
IL-13, Session 3, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 3, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 3, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 3, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 3, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-13, Session 4, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-13, Session 4, Day 1, predose, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-13, Session 4, Day 1, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-13, Session 4, Day 1, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-13, Session 4, Day 1, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-13, Session 4, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-13, Session 4, Day 3, predose, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-13, Session 4, Day 3, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-13, Session 4, Day 3, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-13, Session 4, Day 3, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-13, Session 4, Day 4, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-13, Session 4, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 5, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 5, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 5, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 5, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 5, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 5, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 5, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 5, Day 3, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.283  (0.5650)
IL-13, Session 5, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 5, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 5, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 5, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 6, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 6, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 6, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 6, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 6, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 6, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 6, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 6, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 6, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-13, Session 6, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
0.488  (0.9750)
IL-13, Session 6, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 1, Day 1, predose, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-2, Session 1, Day 1, 1 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-2, Session 1, Day 1, 3 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-2, Session 1, Day 1, 6 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-2, Session 1, Day 2, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-2, Session 1, Day 3, predose, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-2, Session 1, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 1, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 1, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 1, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 1, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 2, Day -2, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 2, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 2, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 2, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 2, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 2, Day 2, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 2, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 2, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 2, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 2, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 2, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 2, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 3, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-2, Session 3, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 3, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 3, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 3, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 3, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-2, Session 3, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 3, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 3, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 3, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 3, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 3, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-2, Session 4, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-2, Session 4, Day 1, predose, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-2, Session 4, Day 1, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-2, Session 4, Day 1, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-2, Session 4, Day 1, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-2, Session 4, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-2, Session 4, Day 3, predose, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-2, Session 4, Day 3, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-2, Session 4, Day 3, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-2, Session 4, Day 3, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-2, Session 4, Day 4, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-2, Session 4, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 5, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 5, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 5, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 5, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 5, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 5, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 5, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 5, Day 3, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 5, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 5, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 5, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 5, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 6, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 6, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 6, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 6, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 6, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 6, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 6, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 6, Day 3, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 6, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 6, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 6, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-2, Session 6, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 1, Day 1, predose, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-4, Session 1, Day 1, 1 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-4, Session 1, Day 1, 3 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-4, Session 1, Day 1, 6 hour, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-4, Session 1, Day 2, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-4, Session 1, Day 3, predose, n=6,1 Number Analyzed 6 participants 1 participants
0.000  (0.0000) 0.000 [1]   (NA)
IL-4, Session 1, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 1, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 1, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 1, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 1, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 2, Day -2, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 2, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 2, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 2, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 2, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 2, Day 2, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 2, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 2, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 2, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 2, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 2, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 2, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 3, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-4, Session 3, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 3, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 3, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 3, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 3, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-4, Session 3, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 3, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 3, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 3, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 3, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 3, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
0.000  (0.0000)
IL-4, Session 4, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-4, Session 4, Day 1, predose, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-4, Session 4, Day 1, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-4, Session 4, Day 1, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-4, Session 4, Day 1, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-4, Session 4, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-4, Session 4, Day 3, predose, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-4, Session 4, Day 3, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-4, Session 4, Day 3, 3 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-4, Session 4, Day 3, 6 hour, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-4, Session 4, Day 4, n=5,0 Number Analyzed 5 participants 0 participants
0.000  (0.0000)
IL-4, Session 4, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 5, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 5, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 5, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 5, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 5, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 5, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 5, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 5, Day 3, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 5, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 5, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 5, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 5, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 6, Day -2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 6, Day 1, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 6, Day 1, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 6, Day 1, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 6, Day 1, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 6, Day 2, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 6, Day 3, predose, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 6, Day 3, 1 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 6, Day 3, 3 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 6, Day 3, 6 hour, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 6, Day 4, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-4, Session 6, Day 5, n=4,0 Number Analyzed 4 participants 0 participants
0.000  (0.0000)
IL-8, Session 1, Day 1, predose, n=6,1 Number Analyzed 6 participants 1 participants
4.377  (5.8881) 1.140 [1]   (NA)
IL-8, Session 1, Day 1, 1 hour, n=6,1 Number Analyzed 6 participants 1 participants
4.887  (12.0436) 0.450 [1]   (NA)
IL-8, Session 1, Day 1, 3 hour, n=6,1 Number Analyzed 6 participants 1 participants
1.097  (6.7834) 0.480 [1]   (NA)
IL-8, Session 1, Day 1, 6 hour, n=6,1 Number Analyzed 6 participants 1 participants
4.400  (9.5000) 8.350 [1]   (NA)
IL-8, Session 1, Day 2, n=6,1 Number Analyzed 6 participants 1 participants
10.977  (25.4607) 12.720 [1]   (NA)
IL-8, Session 1, Day 3, predose, n=6,1 Number Analyzed 6 participants 1 participants
6.830  (10.6309) 9.350 [1]   (NA)
IL-8, Session 1, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
3.035  (6.9193)
IL-8, Session 1, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
-0.788  (4.9840)
IL-8, Session 1, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
-0.490  (7.3654)
IL-8, Session 1, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
-0.542  (5.0480)
IL-8, Session 1, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
1.198  (3.0063)
IL-8, Session 2, Day -2, n=6,0 Number Analyzed 6 participants 0 participants
7.848  (12.9271)
IL-8, Session 2, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
4.920  (8.3853)
IL-8, Session 2, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
1.592  (6.9965)
IL-8, Session 2, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.275  (7.2669)
IL-8, Session 2, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
1.243  (6.1976)
IL-8, Session 2, Day 2, n=6,0 Number Analyzed 6 participants 0 participants
5.468  (7.5652)
IL-8, Session 2, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
8.322  (5.0082)
IL-8, Session 2, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
6.432  (10.6402)
IL-8, Session 2, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
-1.107  (5.8160)
IL-8, Session 2, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
-0.870  (4.6278)
IL-8, Session 2, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
1.667  (5.5170)
IL-8, Session 2, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
2.853  (5.4769)
IL-8, Session 3, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
12.742  (7.8571)
IL-8, Session 3, Day 1, predose, n=6,0 Number Analyzed 6 participants 0 participants
7.635  (6.3602)
IL-8, Session 3, Day 1, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
3.848  (5.5264)
IL-8, Session 3, Day 1, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
-0.517  (5.6983)
IL-8, Session 3, Day 1, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.933  (8.0166)
IL-8, Session 3, Day 2, n=5,0 Number Analyzed 5 participants 0 participants
3.024  (5.5819)
IL-8, Session 3, Day 3, predose, n=6,0 Number Analyzed 6 participants 0 participants
14.440  (13.4971)
IL-8, Session 3, Day 3, 1 hour, n=6,0 Number Analyzed 6 participants 0 participants
4.887  (5.2130)
IL-8, Session 3, Day 3, 3 hour, n=6,0 Number Analyzed 6 participants 0 participants
0.088  (4.3970)
IL-8, Session 3, Day 3, 6 hour, n=6,0 Number Analyzed 6 participants 0 participants
2.450  (6.2029)
IL-8, Session 3, Day 4, n=6,0 Number Analyzed 6 participants 0 participants
3.680  (4.5662)
IL-8, Session 3, Day 5, n=6,0 Number Analyzed 6 participants 0 participants
7.783  (3.9382)
IL-8, Session 4, Day -2, n=5,0 Number Analyzed 5 participants 0 participants
15.686  (10.4436)
IL-8, Session 4, Day 1, predose, n=5,0 Number Analyzed 5 participants 0 participants
9.910  (11.2178)
IL-8, Session 4, Day 1, 1 hour, n=5,0 Number Analyzed 5 participants 0 participants
10.088  (13.7154)
IL-8, Session 4, Day 1, 3 hour, n=5,0 Number Analyzed