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Safety and Tolerability Study of Xisomab 3G3 in Healthy Adult Subjects

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: NCT03097341
Recruitment Status : Completed
First Posted : March 31, 2017
Results First Posted : May 20, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Aronora, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Thrombosis
Interventions Drug: xisomab 3G3- Dose 1
Drug: xisomab 3G3-Dose 2
Drug: xisomab 3G3-Dose 3
Drug: xisomab 3G3- Dose 4
Other: Placebo
Enrollment 21
Recruitment Details  
Pre-assignment Details A total of 105 participants were screened for the study, of which 84 did not meet eligibility criteria or declined to participate. The remaining 21 participants were randomized into the study, with each dose level occurring in sequential order.
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4 Placebo
Hide Arm/Group Description Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3. Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3. Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3. Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3. Participants received a single intravenous dose of placebo.
Period Title: Overall Study
Started 4 4 4 4 5
Completed 4 4 4 4 5
Not Completed 0 0 0 0 0
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4 Placebo Total
Hide Arm/Group Description Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3. Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3. Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3. Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3. Participants received a single intravenous dose of placebo. Total of all reporting groups
Overall Number of Baseline Participants 4 4 4 4 5 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 4 participants 4 participants 4 participants 4 participants 5 participants 21 participants
42.3
(37 to 47)
33.0
(25 to 46)
32.0
(22 to 42)
42.0
(40 to 45)
32.2
(25 to 42)
36.1
(22 to 47)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 5 participants 21 participants
Female
3
  75.0%
2
  50.0%
1
  25.0%
1
  25.0%
2
  40.0%
9
  42.9%
Male
1
  25.0%
2
  50.0%
3
  75.0%
3
  75.0%
3
  60.0%
12
  57.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 5 participants 21 participants
Hispanic or Latino
4
 100.0%
3
  75.0%
3
  75.0%
3
  75.0%
4
  80.0%
17
  81.0%
Not Hispanic or Latino
0
   0.0%
1
  25.0%
1
  25.0%
1
  25.0%
1
  20.0%
4
  19.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 4 participants 4 participants 4 participants 5 participants 21 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
1
   4.8%
White
4
 100.0%
3
  75.0%
4
 100.0%
3
  75.0%
5
 100.0%
19
  90.5%
More than one race
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants 4 participants 4 participants 4 participants 5 participants 21 participants
4 4 4 4 5 21
1.Primary Outcome
Title The Number of Subjects With Treatment-related Adverse Events (TEAEs) Will be Summarized Using Frequency Counts.
Hide Description TEAEs will be determined by physical examination that will include assessment of skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, gastrointestinal system, neurological condition, blood and lymphatic systems, and the musculoskeletal system.
Time Frame From Subject Check-In through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who received any dose of study drug or placebo were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
1
  25.0%
3
  75.0%
1
  25.0%
2
  50.0%
3
  60.0%
2.Primary Outcome
Title The Number of Subjects With Abnormal Vital Signs That Are Related to Treatment Will be Summarized Using Frequency Counts..
Hide Description Vital sign measurements (body temperature, respiratory rate, blood pressure, and heart rate)
Time Frame From subject Check-In through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
3.Primary Outcome
Title The Number of Subjects With Abnormal Electrocardiogram That is Related to Treatment Will be Summarized Using Frequency Counts..
Hide Description 12-lead electrocardiogram measurement
Time Frame From subject Check-In through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 4
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title The Number of Subjects With Abnormal Injection Site Reaction That Are Related to Treatment Will be Summarized Using Frequency Counts..
Hide Description Injection site reaction (pain, tenderness, erythema/ redness, and induration/ swelling)
Time Frame From Study Day 1 through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Primary Outcome
Title The Number of Subjects With Abnormal Laboratory Values and/ or Adverse Events That Are Related to Treatment Will be Summarized Using Frequency Counts..
Hide Description Clinical laboratory tests include serum chemistry, hematology, coagulation parameters (aPTT, PT, and bleeding time), and urinalysis
Time Frame From subject Check-In through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Primary Outcome
Title The Number of Subjects That Develop Treatment-related Immunogenicity Will be Summarized Using Frequency Counts.
Hide Description Immunogenicity measured by the presence of plasma anti-drug antibodies
Time Frame From Study Day 1 through Follow up. Follow up was performed 7 days after Day 29. If the aPTT was not +/- 10% baseline or within normal range, subject was monitored weekly until baseline reached and follow up then occured 7 days after.
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to the treatment they actually received.
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Measure Type: Count of Participants
Unit of Measure: Participants
Pre-dose (baseline)
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Day 15
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Day 29 or follow up
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title The Maximum Plasma Concentration (Cmax) of Xisomab 3G3 After a Single Injection Will be Measured in Each Subject.
Hide Description Maximum plasma concentration of xisomab 3G3 was estimated based on plasma xisomab 3G3 concentrations. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time Frame Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Overall Number of Participants Analyzed 3 4 4 4
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanograms/milliliter
122.7
(23.3%)
11210
(9.1%)
42510
(12.3%)
127200
(2.6%)
8.Secondary Outcome
Title The Time to Reach Maximum Plasma Concentrations of Xisomab 3G3 (Tmax) After a Single Injection Will be Measured in Each Subject.
Hide Description The time to reach maximum plasma concentrations of xisomab 3G3 after a single injection was estimated based on plasma xisomab 3G3 concentrations. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time Frame Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Overall Number of Participants Analyzed 3 4 4 4
Median (Full Range)
Unit of Measure: hours
0.084
(0.08 to 0.09)
0.649
(0.26 to 3.02)
0.088
(0.08 to 0.25)
0.387
(0.26 to 3.00)
9.Secondary Outcome
Title The Area Under the Plasma Concentration-time Curve From Time 0 to the Last Measurable Non-zero Concentration (AUC0-t), as Calculated by the Linear Trapezoidal Method, After a Single Injection of Xisomab 3G3 Will be Calculated for Each Subject.
Hide Description The area under the plasma concentration-time curve from time 0 to the last measurable non-zero concentration was estimated based on plasma xisomab 3G3 concentrations. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time Frame Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Overall Number of Participants Analyzed 3 4 4 4
Mean (Standard Deviation)
Unit of Measure: nanograms*hour/milliliter
57.0  (46.5) 361800  (21.9) 5540000  (23.9) 28120000  (11.8)
10.Secondary Outcome
Title The Area Under the Plasma Concentration-time Curve From Time 0 Extrapolated to Infinity (AUC0-inf) After a Single Injection of Xisomab 3G3 Will be Calculated for Each Subject.
Hide Description The area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUC0-inf) is calculated as the sum of AUC0-t plus the ratio of the last measurable plasma concentration to the elimination rate constant. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time Frame Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Overall Number of Participants Analyzed 1 4 4 4
Mean (Standard Deviation)
Unit of Measure: nanogram*hour/milliliter
184.7 363700  (21.8) 5550000  (24.0) 28140000  (11.8)
11.Secondary Outcome
Title The Percent of AUC0-inf Extrapolated (AUC%Extrap) After a Single Injection of Xisomab 3G3 Will be Calculated for Each Subject.
Hide Description The percent of AUC0-inf extrapolated (AUC%extrap) is calculated by (1-AUC0-t/AUC0-inf)*100. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time Frame Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Overall Number of Participants Analyzed 1 4 4 4
Mean (Standard Deviation)
Unit of Measure: percentage of AUC0-inf
57.3 0.53  (0.18) 0.18  (0.07) 0.07  (0.04)
12.Secondary Outcome
Title The Apparent First Order Terminal Elimination Rate Constant (Kel) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject.
Hide Description The apparent first order terminal elimination rate constant will be calculated from a semi-log plot of the plasma concentration versus time curve. The parameter will be calculated by linear least squares regression analysis using the maximum number of points in the terminal log linear phase (e.g., three or more non zero plasma concentrations). Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time Frame Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Overall Number of Participants Analyzed 1 4 4 4
Mean (Standard Deviation)
Unit of Measure: 1/hour
0.522 0.042  (0.0042) 0.011  (0.0009) 0.006  (0.0018)
13.Secondary Outcome
Title The Apparent First Order Terminal Elimination Half-life (T1/2) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject.
Hide Description The apparent first order terminal elimination half-life will be calculated as 0.693/Kel. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time Frame Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Overall Number of Participants Analyzed 1 4 4 4
Mean (Standard Deviation)
Unit of Measure: hours
1.33 16.64  (1.56) 60.63  (4.45) 121.49  (40.69)
14.Secondary Outcome
Title The Apparent Total Plasma Clearance (CL) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject.
Hide Description The apparent total plasma clearance will be calculated as [Dose/AUC0-inf]. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time Frame Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
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Hide Analysis Population Description
All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Overall Number of Participants Analyzed 1 4 4 4
Mean (Standard Deviation)
Unit of Measure: Liters/hour
37.46 0.094  (0.018) 0.026  (0.003) 0.014  (0.003)
15.Secondary Outcome
Title The Total Apparent Volume of Distribution (Vss) of Xisomab 3G3 After a Single Intravenous Injection Will be Calculated for Each Subject.
Hide Description The total apparent volume of distribution (Vss) will be calculated as the mean residence time x clearance. Non-compartmental PK data analysis was performed to estimate the plasma PK parameters of xisomab 3G3.
Time Frame Pre-dose (0.5h prior to dose), 0.083, 0.25, 0.5, 1,3,8,24,72,120, 168, 216, 336, 504, 672h after dosing as well as follow up (7 days after aPTT returned back to baseline).
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Hide Analysis Population Description
All subjects who were enrolled in, received the active treatment, completed the study, and had an evaluable PK profile were included in the PK analysis.
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Overall Number of Participants Analyzed 1 4 4 4
Mean (Standard Deviation)
Unit of Measure: Liters
69.11 2.52  (0.59) 3.72  (0.42) 4.31  (0.75)
16.Secondary Outcome
Title The Effect of a Single Intravenous Dose of Xisomab 3G3 on the Activated Partial Thromboplastin Time (aPTT) in Healthy Adult Subjects Will be Measured.
Hide Description Activated partial thromboplastin time (aPTT) will be used as a surrogate pharmacodynamic marker.
Time Frame Pre-dose (0.5h prior to dose), 1, 24,72, 168, 336, 504, 672h after dosing as well as follow up (7 days after day 29 or after aPTT returned back to baseline)..
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Hide Analysis Population Description
All subjects who had received any dose of study drug were included in the as-treated population and subjects were analyzed according to treatment.
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4 Placebo
Hide Arm/Group Description:
Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3.
Participants received a single intravenous dose of placebo.
Overall Number of Participants Analyzed 4 4 4 4 5
Mean (Standard Deviation)
Unit of Measure: seconds
pre-dose 27.0  (1.8) 26.5  (1.3) 26.3  (2.6) 27.5  (1.7) 29.4  (1.7)
Day 1, Hour 1 32.8  (3.8) 48.3  (0.5) 53.3  (5.7) 57.3  (7.8) 29.4  (1.7)
Day 2 29.0  (2.3) 50.5  (5.8) 52.5  (4.8) 55.8  (6.9) 28.8  (2.0)
Day 4 28.3  (2.6) 48.8  (6.5) 49.8  (3.9) 52.3  (5.6) 27.3  (2.1)
Day 8 27.3  (2.1) 30.5  (3.9) 47.3  (2.2) 49.8  (5.3) 28.6  (1.1)
Day 15 26.8  (2.1) 27.5  (2.1) 47.0  (2.9) 48.0  (6.5) 29.0  (1.2)
Day 22 26.5  (2.4) 27.5  (2.6) 39.5  (6.6) 48.3  (6.3) 28.8  (0.8)
Day 29 27.0  (2.3) 27.5  (2.1) 30.3  (2.9) 47.3  (5.0) 29.2  (1.3)
Follow Up 26.8  (1.5) 27.3  (1.7) 28.3  (1.5) 28.0  (2.2) 29.2  (1.3)
Time Frame Adverse events were recorded from subject check-in through follow-up. Follow-up was performed 7 days after day 29. Subjects for whom aPTT did not reach +/- 10% of baseline or within normal range by Study Day 29 returned every 7 days until aPTT reached within +/- 10% of baseline or within normal range and the follow up visit was conducted 7 days after it was reached.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4 Placebo
Hide Arm/Group Description Participants received a single intravenous dose of 0.1 mg/kg xisomab 3G3. Participants received a single intravenous dose of 0.5 mg/kg xisomab 3G3. Participants received a single intravenous dose of 2.0 mg/kg xisomab 3G3. Participants received a single intravenous dose of 5.0 mg/kg xisomab 3G3. Participants received a single intravenous dose of placebo.
All-Cause Mortality
Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4 Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/5 (0.00%)    
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Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/4 (0.00%)      0/5 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Xisomab 3G3- Dose 1 Xisomab 3G3- Dose 2 Xisomab 3G3- Dose 3 Xisomab 3G3- Dose 4 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/4 (25.00%)      3/4 (75.00%)      1/4 (25.00%)      2/4 (50.00%)      3/5 (60.00%)    
Ear and labyrinth disorders           
Ear pain † 1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Middle ear effusion † 1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Gastrointestinal disorders           
Toothache † 1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
General disorders           
Injection site ecchymosis † 1 [1]  0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Injection site pain † 1 [1]  0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Infections and infestations           
Upper respiritory tract infection † 1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Viral infection † 1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1
Investigations           
Blood pressure diastolic increased † 1  0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/5 (0.00%)  0
Nervous system disorders           
Headache † 1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Presyncope † 1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders           
Oralpharangeal pain † 1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Productive cough † 1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0
Skin and subcutaneous tissue disorders           
Dermatitis contact † 1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1
Ecchymosis † 1  1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Pruritus † 1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1
Pruritus generalized † 1  0/4 (0.00%)  0 1/4 (25.00%)  1 0/4 (0.00%)  0 0/4 (0.00%)  0 0/5 (0.00%)  0
Rash papular † 1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/5 (20.00%)  1
Skin discoloration † 1  0/4 (0.00%)  0 0/4 (0.00%)  0 0/4 (0.00%)  0 1/4 (25.00%)  1 0/5 (0.00%)  0
1
Term from vocabulary, MedDRA (20.0)
†
Indicates events were collected by systematic assessment
[1]
administration site condition
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Aronora shall retain title to and the right to publish all documentation, records, raw data, specimens or other work product generated in connection with this study. Such publications shall not be made by the PI or Celerion without the prior written consent of Aronora.
Results Point of Contact
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Name/Title: Christina U. Lorentz, PhD, Senior Scientist and Project Manager
Organization: Aronora, Inc.
Phone: 503-964-0250
EMail: christina.lorentz@aronorabio.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Aronora, Inc.
ClinicalTrials.gov Identifier: NCT03097341    
Other Study ID Numbers: 3G3-15-01
First Submitted: March 21, 2017
First Posted: March 31, 2017
Results First Submitted: February 15, 2019
Results First Posted: May 20, 2019
Last Update Posted: June 5, 2019