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Trial record 1 of 1 for:    NCT03486990
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Study of the Safety, Tolerability and Pharmacokinetics of TIMP-GLIA in Subjects With Celiac Disease

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ClinicalTrials.gov Identifier: NCT03486990
Recruitment Status : Completed
First Posted : April 3, 2018
Results First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Collaborator:
COUR Pharmaceutical Development Company, Inc.
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Celiac Disease
Intervention Drug: TIMP-GLIA
Enrollment 23
Recruitment Details Participants took part in the study at 5 investigative sites in the United States from 23 January 2018 to 22 July 2019.
Pre-assignment Details Participants diagnosed with celiac disease (CD) were enrolled to receive TIMP-GLIA as a single dose escalation of 0.1 milligram per kilogram (mg/kg), 0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 4.0 mg/kg, 8.0 mg/kg in Part A; and TIMP-GLIA as a two dose escalation of 2.0 mg/kg, 4.0 mg/kg, 8.0 mg/kg in Part B.
Arm/Group Title Part A, Cohort 1: 0.1 mg/kg Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8. TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8. TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Period Title: Overall Study
Started 2 2 3 3 3 4 2 2 2
Completed 2 2 3 3 3 4 2 2 2
Not Completed 0 0 0 0 0 0 0 0 0
Arm/Group Title Part A, Cohort 1: 0.1 mg/kg Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg Total
Hide Arm/Group Description TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8. TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8. TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8. Total of all reporting groups
Overall Number of Baseline Participants 2 2 3 3 3 4 2 2 2 23
Hide Baseline Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 2 participants 2 participants 3 participants 3 participants 3 participants 4 participants 2 participants 2 participants 2 participants 23 participants
38.5  (27.58) 53.5  (20.51) 39.3  (15.57) 38.0  (4.58) 48.3  (14.19) 27.5  (4.65) 42.5  (13.44) 53.5  (7.78) 32.5  (2.12) 40.3  (13.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 3 participants 3 participants 3 participants 4 participants 2 participants 2 participants 2 participants 23 participants
Female
2
 100.0%
1
  50.0%
2
  66.7%
2
  66.7%
3
 100.0%
3
  75.0%
2
 100.0%
2
 100.0%
1
  50.0%
18
  78.3%
Male
0
   0.0%
1
  50.0%
1
  33.3%
1
  33.3%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
1
  50.0%
5
  21.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 3 participants 3 participants 3 participants 4 participants 2 participants 2 participants 2 participants 23 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.3%
Not Hispanic or Latino
2
 100.0%
2
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
3
  75.0%
2
 100.0%
2
 100.0%
2
 100.0%
22
  95.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
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 2 participants 2 participants 3 participants 3 participants 3 participants 4 participants 2 participants 2 participants 2 participants 23 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
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%
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%
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%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
2
 100.0%
2
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
3
  75.0%
2
 100.0%
2
 100.0%
2
 100.0%
22
  95.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  25.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 3 participants 3 participants 3 participants 4 participants 2 participants 2 participants 2 participants 23 participants
2
 100.0%
2
 100.0%
3
 100.0%
3
 100.0%
3
 100.0%
4
 100.0%
2
 100.0%
2
 100.0%
2
 100.0%
23
 100.0%
1.Primary Outcome
Title Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame From Day 1 up to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Arm/Group Title Part A, Cohort 1: 0.1 mg/kg Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 3 3 3 4 2 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
1
  50.0%
2
 100.0%
3
 100.0%
3
 100.0%
2
  66.7%
3
  75.0%
1
  50.0%
1
  50.0%
2
 100.0%
SAEs
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Participants With Grade 3 or Higher TEAEs and Drug-related Adverse Events
Hide Description AE Grades will be evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE), version 4.0. Grade 1 scaled as Mild; Grade 2 scaled as Moderate; Grade 3 scaled as severe or medically significant but not immediately life-threatening; Grade 4 scaled as life-threatening consequences; and Grade 5 scaled as death related to AE. Drug-related adverse events are those that the investigator assessed as possibly or probably related to the study treatment.
Time Frame From Day 1 up to Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Arm/Group Title Part A, Cohort 1: 0.1 mg/kg Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 3 3 3 4 2 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
Grade 3 or Higher TEAEs
0
   0.0%
0
   0.0%
1
  33.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Drug-related Adverse Events
1
  50.0%
0
   0.0%
2
  66.7%
2
  66.7%
2
  66.7%
3
  75.0%
0
   0.0%
1
  50.0%
1
  50.0%
3.Primary Outcome
Title Number of Participants With Clinically Significant Physical Examination Findings
Hide Description [Not Specified]
Time Frame From Day 1 up to Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Arm/Group Title Part A, Cohort 1: 0.1 mg/kg Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 3 3 3 4 2 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Number of Participants With Clinically Significant Electrocardiograms (ECG) Findings
Hide Description [Not Specified]
Time Frame From Day 1 up to Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Arm/Group Title Part A, Cohort 1: 0.1 mg/kg Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 3 3 3 4 2 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
5.Primary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Arterial Oxygen Saturation Levels
Hide Description [Not Specified]
Time Frame From Day 1 up to Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Arm/Group Title Part A, Cohort 1: 0.1 mg/kg Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 3 3 3 4 2 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
6.Primary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values
Hide Description [Not Specified]
Time Frame From Day 1 up to Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Arm/Group Title Part A, Cohort 1: 0.1 mg/kg Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 3 3 3 4 2 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
7.Primary Outcome
Title Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 3
Hide Description Baseline is defined as Day 1 pre-dose.
Time Frame Baseline (Day 1 pre-dose) and Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Arm/Group Title Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 2
Mean (Standard Deviation)
Unit of Measure: units per milliliter (U/ml)
Baseline (Day 1 pre-dose) 2.15  (0.495) 2.85  (0.778) 3.30  (0.990)
Change at Day 3 1.20  (0.000) 0.60  (0.141) -0.35  (0.071)
8.Primary Outcome
Title Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 7
Hide Description Baseline is defined as Day 1 pre-dose.
Time Frame Baseline (Day 1 pre-dose) and Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Arm/Group Title Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 2
Mean (Standard Deviation)
Unit of Measure: U/ml
Baseline (Day 1 pre-dose) 2.15  (0.495) 2.85  (0.778) 3.30  (0.990)
Change at Day 7 0.75  (0.071) 0.00  (0.000) 0.85  (1.344)
9.Primary Outcome
Title Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 8
Hide Description Baseline is defined as Day 1 pre-dose.
Time Frame Baseline (Day 1 pre-dose) and Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. The safety analysis population where data at specified time points were available.
Arm/Group Title Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 2
Mean (Standard Deviation)
Unit of Measure: U/ml
Baseline (Day 1 pre-dose) Number Analyzed 2 participants 2 participants 2 participants
2.15  (0.495) 2.85  (0.778) 3.30  (0.990)
Change at Day 8 Number Analyzed 2 participants 1 participants 2 participants
0.70  (0.141) 0.10 [1]   (NA) 1.50  (1.838)
[1]
Standard deviation could not be calculated since only 1 participant was available for analysis.
10.Primary Outcome
Title Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 10
Hide Description Baseline is defined as Day 1 pre-dose.
Time Frame Baseline (Day 1 pre-dose) and Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Arm/Group Title Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 2
Mean (Standard Deviation)
Unit of Measure: U/ml
Baseline (Day 1 pre-dose) 2.15  (0.495) 2.85  (0.778) 3.30  (0.990)
Change at Day 10 1.85  (0.778) 1.00  (1.273) 1.25  (1.485)
11.Primary Outcome
Title Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 14
Hide Description Baseline is defined as Day 1 pre-dose.
Time Frame Baseline (Day 1 pre-dose) and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Arm/Group Title Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 2
Mean (Standard Deviation)
Unit of Measure: U/ml
Baseline (Day 1 pre-dose) 2.15  (0.495) 2.85  (0.778) 3.30  (0.990)
Change at Day 14 0.90  (0.141) 1.65  (0.495) 1.30  (1.273)
12.Primary Outcome
Title Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 38
Hide Description Baseline is defined as Day 1 pre-dose.
Time Frame Baseline (Day 1 pre-dose) and Day 38
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA. The safety analysis population where data at specified time points were available.
Arm/Group Title Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 2
Mean (Standard Deviation)
Unit of Measure: U/ml
Baseline (Day 1 pre-dose) Number Analyzed 2 participants 2 participants 2 participants
2.15  (0.495) 2.85  (0.778) 3.30  (0.990)
Change at Day 38 Number Analyzed 1 participants 2 participants 2 participants
0.30 [1]   (NA) 1.50  (1.273) 1.00  (1.980)
[1]
Standard deviation could not be calculated since only 1 participant was available for analysis.
13.Primary Outcome
Title Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 60
Hide Description Baseline is defined as Day 1 pre-dose.
Time Frame Baseline (Day 1 pre-dose) and Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Arm/Group Title Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 2
Mean (Standard Deviation)
Unit of Measure: U/ml
Baseline (Day 1 pre-dose) 2.15  (0.495) 2.85  (0.778) 3.30  (0.990)
Change at Day 60 0.65  (0.354) 1.15  (1.061) 1.10  (1.838)
14.Primary Outcome
Title Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 15 Minutes Post-dose on Day 1
Hide Description Baseline was defined as Day 1 Pre-dose.
Time Frame Baseline (Day 1 pre-dose) and 15 minutes (min) post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Arm/Group Title Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 2
Mean (Standard Deviation)
Unit of Measure: nanogram per milliliter (ng/mL)
Baseline (Day 1 pre-dose): C3a level 32.25  (23.264) 16.15  (0.636) 18.65  (17.041)
Change at 15 min post-dose on Day 1: C3a level 45.40  (43.841) 134.90  (104.369) 46.25  (13.930)
Baseline (Day 1 pre-dose): SC5B-9 level 109.5  (17.68) 95.5  (33.23) 112.0  (33.94)
Change at 15 min post-dose on Day 1: SC5B-9 level 59.0  (49.50) 196.0  (193.75) 130.5  (33.23)
15.Primary Outcome
Title Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 30 Minutes Post-dose on Day 1
Hide Description Baseline was defined as Day 1 Pre-dose.
Time Frame Baseline (Day 1 pre-dose) and 30 min post-dose on Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Arm/Group Title Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline (Day 1 pre-dose): C3a level 32.25  (23.264) 16.15  (0.636) 18.65  (17.041)
Change at 30 min post-dose on Day 1: C3a level 87.50  (56.569) 144.00  (11.455) 65.65  (34.719)
Baseline (Day 1 pre-dose): SC5B-9 level 109.5  (17.68) 95.5  (33.23) 112.0  (33.94)
Change at 30 min post-dose on Day 1: SC5B-9 level 179.0  (2.83) 307.0  (41.01) 293.0  (185.26)
16.Primary Outcome
Title Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at Day 2
Hide Description Baseline was defined as Day 1 Pre-dose.
Time Frame Baseline (Day 1 pre-dose) and Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Arm/Group Title Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 2
Mean (Standard Deviation)
Unit of Measure: ng/mL
Baseline (Day 1 pre-dose): C3a level 32.25  (23.264) 16.15  (0.636) 18.65  (17.041)
Change at Day 2: C3a level -6.55  (12.092) 0.90  (0.990) -6.70  (20.789)
Baseline (Day 1 pre-dose): SC5B-9 level 109.5  (17.68) 95.5  (33.23) 112.0  (33.94)
Change at Day 2: SC5B-9 level 26.0  (14.14) -12.5  (36.06) 2.0  (22.63)
17.Primary Outcome
Title Number of Participants With Clinically Significant Change From Baseline in Hematology, Serum Chemistry, Coagulation, and Urinalysis
Hide Description [Not Specified]
Time Frame From Day 1 up to Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Arm/Group Title Part A, Cohort 1: 0.1 mg/kg Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 3 3 3 4 2 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
18.Primary Outcome
Title Part A (Greater Than or Equal to [>=] 4.0 mg/kg) and Part B: Number of Participants With Clinically Significant Change From Baseline in Gliadin-Specific T-cell Proliferation and Cytokine Release Markers
Hide Description [Not Specified]
Time Frame Part A (>=4.0 mg/kg): Day 1 pre-dose up to 144 hours post-dose on Day 7; Part B: Day 8 pre-dose up to 144 hours post-dose on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Arm/Group Title Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 3 4 2 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
19.Primary Outcome
Title Number of Participants With Clinically Significant Laboratory Abnormalities
Hide Description [Not Specified]
Time Frame From Day 1 up to Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Arm/Group Title Part A, Cohort 1: 0.1 mg/kg Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 2 3 3 3 4 2 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
  50.0%
20.Secondary Outcome
Title Cmax: Maximum Observed Plasma Concentration For TIMP-GLIA
Hide Description [Not Specified]
Time Frame Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The pharmacokinetic (PK) population who received at least 1 dose of TIMP-GLIA and had at least 1 PK parameter reported. The PK analysis population where data at specified time points were available.
Arm/Group Title Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 3 3 3 3 2 2 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: nanogram per milliliter (ng/mL)
Day 1 Number Analyzed 2 participants 3 participants 3 participants 3 participants 0 participants 2 participants 2 participants 2 participants
91.8
(48.4%)
220
(3.0%)
457
(17.6%)
845
(23.6%)
252
(6.7%)
529
(22.6%)
938
(2.9%)
Day 8 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 2 participants 2 participants
NA [1] 
(NA%)
408
(26.8%)
735
(11.7%)
[1]
Data was not calculated in more than 1/3 of participants due to poor or incomplete profile and not estimable in WinNonLin, or Percent of area under the plasma concentration-time curve extrapolated to infinity (%AUCextrap) exceeds 25%.
21.Secondary Outcome
Title Clast: Last Measurable Observed Plasma Concentration For TIMP-GLIA
Hide Description [Not Specified]
Time Frame Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population who received at least 1 dose of TIMP-GLIA and had at least 1 PK parameter reported. The PK analysis population where data at specified time points were available.
Arm/Group Title Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 3 3 3 3 2 2 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
Day 1 Number Analyzed 2 participants 3 participants 3 participants 3 participants 3 participants 2 participants 2 participants 2 participants
50.6
(12.2%)
63.9
(29.2%)
68.6
(27.2%)
55.8
(30.2%)
77.2
(23.7%)
97.9
(85.1%)
47.9
(19.0%)
111
(5.7%)
Day 8 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 2 participants 2 participants
NA [1] 
(NA%)
133
(137.7%)
54.4
(19.5%)
[1]
Data was not calculated in more than 1/3 of participants due to poor or incomplete profile and not estimable in WinNonLin, or %AUCextrap exceeds 25%.
22.Secondary Outcome
Title Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TIMP-GLIA
Hide Description [Not Specified]
Time Frame Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population who received at least 1 dose of TIMP-GLIA and had at least 1 PK parameter reported. The PK analysis population where data at specified time points were available.
Arm/Group Title Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 3 3 3 3 2 2 2
Median (Full Range)
Unit of Measure: hour
Day 1 Number Analyzed 2 participants 3 participants 3 participants 3 participants 0 participants 2 participants 2 participants 2 participants
0.54
(0.50 to 0.58)
0.50
(0.50 to 0.58)
0.50
(0.50 to 0.58)
0.50
(0.50 to 0.58)
2.86
(2.85 to 2.87)
3.21
(2.82 to 3.60)
2.94
(2.83 to 3.05)
Day 8 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 2 participants 2 participants
NA [1] 
(NA to NA)
3.08
(2.82 to 3.33)
2.90
(2.80 to 3.00)
[1]
Data was not calculated in more than 1/3 of participants due to poor or incomplete profile and not estimable in WinNonLin, or %AUCextrap exceeds 25%.
23.Secondary Outcome
Title AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TIMP-GLIA
Hide Description [Not Specified]
Time Frame Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population who received at least 1 dose of TIMP-GLIA and had at least 1 PK parameter reported. The PK analysis population where data at specified time points were available.
Arm/Group Title Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 3 3 3 3 2 2 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: hour*nanogram per milliliter (h*ng/mL)
Day 1 Number Analyzed 0 participants 2 participants 2 participants 3 participants 2 participants 1 participants 2 participants 2 participants
604
(3.4%)
3100
(27.0%)
3170
(22.8%)
8430
(48.9%)
NA [1] 
(NA%)
3220
(31.5%)
5080
(9.2%)
Day 8 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 2 participants
NA [1] 
(NA%)
3250
(15.1%)
[1]
Data was not calculated in more than 1/3 of participants due to poor or incomplete profile and not estimable in WinNonLin, or %AUCextrap exceeds 25%.
24.Secondary Outcome
Title AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TIMP-GLIA
Hide Description [Not Specified]
Time Frame Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population who received at least 1 dose of TIMP-GLIA and had at least 1 PK parameter reported. The PK analysis population where data at specified time points were available.
Arm/Group Title Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 3 3 3 3 2 2 2
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: h*ng/mL
Day 1 Number Analyzed 2 participants 3 participants 3 participants 3 participants 3 participants 2 participants 2 participants 2 participants
119
(210.7%)
503
(12.1%)
1690
(88.1%)
2920
(21.6%)
2870
(501.3%)
932
(65.2%)
2930
(30.6%)
4590
(9.6%)
Day 8 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 2 participants 2 participants
NA [1] 
(NA%)
1410
(107.1%)
3050
(14.7%)
[1]
Data was not calculated in more than 1/3 of participants due to poor or incomplete profile and not estimable in WinNonLin, or %AUCextrap exceeds 25%.
25.Secondary Outcome
Title Tlast: Time to Reach the Last Measurable Plasma Concentration for TIMP-GLIA
Hide Description [Not Specified]
Time Frame Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population who received at least 1 dose of TIMP-GLIA and had at least 1 PK parameter reported. The PK analysis population where data at specified time points were available.
Arm/Group Title Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 3 3 3 3 2 2 2
Median (Full Range)
Unit of Measure: hour
Day 1 Number Analyzed 2 participants 3 participants 3 participants 3 participants 3 participants 2 participants 2 participants 2 participants
2.49
(1.00 to 3.98)
4.00
(4.00 to 4.00)
12.17
(4.00 to 24.00)
12.00
(12.00 to 12.17)
12.00
(4.02 to 24.53)
7.99
(4.00 to 11.98)
18.10
(12.20 to 24.00)
12.00
(12.00 to 12.00)
Day 8 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 2 participants 2 participants
NA [1] 
(NA to NA)
8.01
(4.02 to 12.00)
12.08
(12.00 to 12.15)
[1]
Data was not calculated in more than 1/3 of participants due to poor or incomplete profile and not estimable in WinNonLin, or %AUCextrap exceeds 25%.
26.Secondary Outcome
Title T1/2: Terminal Phase Elimination Half-life (T1/2) for TIMP-GLIA
Hide Description [Not Specified]
Time Frame Parts A and B, Day 1: pre-dose and at multiple time points (up to 144 hours) post-dose; Part B, Day 8: pre-dose and at multiple time points (up to 144 hours) post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population who received at least 1 dose of TIMP-GLIA and had at least 1 PK parameter reported. The PK analysis population where data at specified time points were available.
Arm/Group Title Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description:
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
Overall Number of Participants Analyzed 2 3 3 3 3 2 2 2
Median (Full Range)
Unit of Measure: hour
Day 1 Number Analyzed 1 participants 3 participants 3 participants 3 participants 2 participants 1 participants 2 participants 2 participants
NA [1] 
(NA to NA)
1.81
(1.63 to 2.57)
4.38
(1.92 to 8.24)
3.03
(2.86 to 3.35)
4.36
(2.72 to 6.00)
NA [2] 
(NA to NA)
4.60
(2.77 to 6.43)
3.03
(3.02 to 3.04)
Day 8 Number Analyzed 0 participants 0 participants 0 participants 0 participants 0 participants 0 participants 1 participants 2 participants
NA [2] 
(NA to NA)
2.51
(2.46 to 2.56)
[1]
Data was not calculated in more than 1/3 of participants due to poor or incomplete profile and not estimable in WinNonLin, or %AUCextrap exceeds 25%.
[2]
Parameter was not estimable in more than 1/3 of participants due to poor/incomplete profile and not estimable in WinNonLin, or %AUCextrap exceeds 25%.
Time Frame TEAEs are adverse events that started after the first dose of study drug up to Day 180
Adverse Event Reporting Description At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
 
Arm/Group Title Part A, Cohort 1: 0.1 mg/kg Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Hide Arm/Group Description TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1. TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8. TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8. TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
All-Cause Mortality
Part A, Cohort 1: 0.1 mg/kg Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/4 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%) 
Hide Serious Adverse Events
Part A, Cohort 1: 0.1 mg/kg Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)   0/2 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/4 (0.00%)   0/2 (0.00%)   0/2 (0.00%)   0/2 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Part A, Cohort 1: 0.1 mg/kg Part A, Cohort 2: 0.5 mg/kg Part A, Cohort 3: 1.0 mg/kg Part A, Cohort 4: 2.0 mg/kg Part A, Cohort 5: 4.0 mg/kg Part A, Cohort 6: 8.0 mg/kg Part B, Cohort 1: 2.0 mg/kg Part B, Cohort 2: 4.0 mg/kg Part B, Cohort 3: 8.0 mg/kg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/2 (50.00%)   2/2 (100.00%)   3/3 (100.00%)   3/3 (100.00%)   2/3 (66.67%)   3/4 (75.00%)   1/2 (50.00%)   1/2 (50.00%)   2/2 (100.00%) 
Blood and lymphatic system disorders                   
Leukopenia  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Cardiac disorders                   
Sinus tachycardia  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Eye disorders                   
Visual impairment  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Gastrointestinal disorders                   
Abdominal distension  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Abdominal pain  1  1/2 (50.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Colitis  1  0/2 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Diarrhoea  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  2/3 (66.67%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Nausea  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Tongue geographic  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Vomiting  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
General disorders                   
Chills  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Cyst  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Fatigue  1  0/2 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Medical device site erythema  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Vessel puncture site haemorrhage  1  0/2 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Infections and infestations                   
Bronchitis  1  0/2 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Upper respiratory tract infection  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Urinary tract infection  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%) 
Injury, poisoning and procedural complications                   
Contusion  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Infusion related reaction  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/4 (25.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Meniscus injury  1  0/2 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Sunburn  1  0/2 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Investigations                   
Alanine aminotransferase increased  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%) 
Blood creatine phosphokinase increased  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%) 
Fibrin D dimer increased  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Metabolism and nutrition disorders                   
Gluten sensitivity  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  1/2 (50.00%)  0/2 (0.00%)  0/2 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Arthralgia  1  1/2 (50.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Back pain  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/4 (50.00%)  0/2 (0.00%)  1/2 (50.00%)  1/2 (50.00%) 
Muscle tightness  1  0/2 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Myalgia  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Neck pain  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Pain in extremity  1  0/2 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Plantar fasciitis  1  0/2 (0.00%)  0/2 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Nervous system disorders                   
Disturbance in attention  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Headache  1  0/2 (0.00%)  1/2 (50.00%)  1/3 (33.33%)  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  1/2 (50.00%)  1/2 (50.00%)  1/2 (50.00%) 
Paraesthesia  1  1/2 (50.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Reproductive system and breast disorders                   
Vulvovaginal discomfort  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  1/2 (50.00%) 
Respiratory, thoracic and mediastinal disorders                   
Dyspnoea  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Oropharyngeal pain  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/4 (0.00%)  0/2 (0.00%)  1/2 (50.00%)  0/2 (0.00%) 
Skin and subcutaneous tissue disorders                   
Dermatitis contact  1  0/2 (0.00%)  1/2 (50.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/4 (0.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Vascular disorders                   
Flushing  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  2/4 (50.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
Hypotension  1  0/2 (0.00%)  0/2 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/4 (25.00%)  0/2 (0.00%)  0/2 (0.00%)  0/2 (0.00%) 
1
Term from vocabulary, MedDRA 20.1
Indicates events were collected by systematic assessment
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.
Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda’s sole discretion.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Director
Organization: Takeda
Phone: +1-877-825-3327
EMail: trialdisclosures@takeda.com
Layout table for additonal information
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT03486990    
Other Study ID Numbers: TGLIA-5.001
First Submitted: March 21, 2018
First Posted: April 3, 2018
Results First Submitted: May 20, 2020
Results First Posted: June 5, 2020
Last Update Posted: June 5, 2020