Trial Outcomes & Findings for Study of the Safety, Tolerability and Pharmacokinetics of TIMP-GLIA in Subjects With Celiac Disease (NCT NCT03486990)
NCT ID: NCT03486990
Last Updated: 2020-06-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
From Day 1 up to Day 180
Results posted on
2020-06-05
Participant Flow
Participants took part in the study at 5 investigative sites in the United States from 23 January 2018 to 22 July 2019.
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.
Participant milestones
| Measure |
Part A, Cohort 1: 0.1 mg/kg
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
3
|
3
|
3
|
4
|
2
|
2
|
2
|
|
Overall Study
COMPLETED
|
2
|
2
|
3
|
3
|
3
|
4
|
2
|
2
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of the Safety, Tolerability and Pharmacokinetics of TIMP-GLIA in Subjects With Celiac Disease
Baseline characteristics by cohort
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=3 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=3 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=3 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
n=4 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
n=2 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
n=2 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
n=2 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38.5 years
STANDARD_DEVIATION 27.58 • n=99 Participants
|
53.5 years
STANDARD_DEVIATION 20.51 • n=107 Participants
|
39.3 years
STANDARD_DEVIATION 15.57 • n=206 Participants
|
38.0 years
STANDARD_DEVIATION 4.58 • n=157 Participants
|
48.3 years
STANDARD_DEVIATION 14.19 • n=390 Participants
|
27.5 years
STANDARD_DEVIATION 4.65 • n=16 Participants
|
42.5 years
STANDARD_DEVIATION 13.44 • n=3 Participants
|
53.5 years
STANDARD_DEVIATION 7.78 • n=6 Participants
|
32.5 years
STANDARD_DEVIATION 2.12 • n=114 Participants
|
40.3 years
STANDARD_DEVIATION 13.69 • n=23 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
3 Participants
n=16 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
18 Participants
n=23 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=114 Participants
|
5 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
3 Participants
n=16 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
22 Participants
n=23 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
3 Participants
n=16 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
22 Participants
n=23 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
0 Participants
n=23 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
0 Participants
n=390 Participants
|
1 Participants
n=16 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
1 Participants
n=23 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
3 Participants
n=390 Participants
|
4 Participants
n=16 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=114 Participants
|
23 Participants
n=23 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 180Population: The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=3 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=3 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=3 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
n=4 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
n=2 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
n=2 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
n=2 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAEs
|
1 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 180Population: The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
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.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=3 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=3 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=3 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
n=4 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
n=2 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
n=2 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
n=2 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Grade 3 or Higher TEAEs and Drug-related Adverse Events
Grade 3 or Higher TEAEs
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 or Higher TEAEs and Drug-related Adverse Events
Drug-related Adverse Events
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 60Population: The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=3 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=3 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=3 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
n=4 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
n=2 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
n=2 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
n=2 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Physical Examination Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 60Population: The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=3 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=3 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=3 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
n=4 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
n=2 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
n=2 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
n=2 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Electrocardiograms (ECG) Findings
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 60Population: The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=3 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=3 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=3 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
n=4 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
n=2 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
n=2 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
n=2 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Arterial Oxygen Saturation Levels
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 60Population: The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=3 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=3 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=3 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
n=4 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
n=2 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
n=2 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
n=2 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Vital Signs Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Day 3Population: The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Baseline is defined as Day 1 pre-dose.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=2 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 3
Baseline (Day 1 pre-dose)
|
2.15 units per milliliter (U/ml)
Standard Deviation 0.495
|
2.85 units per milliliter (U/ml)
Standard Deviation 0.778
|
3.30 units per milliliter (U/ml)
Standard Deviation 0.990
|
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|
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|
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|
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|
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|
—
|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 3
Change at Day 3
|
1.20 units per milliliter (U/ml)
Standard Deviation 0.000
|
0.60 units per milliliter (U/ml)
Standard Deviation 0.141
|
-0.35 units per milliliter (U/ml)
Standard Deviation 0.071
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Day 7Population: The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Baseline is defined as Day 1 pre-dose.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=2 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 7
Baseline (Day 1 pre-dose)
|
2.15 U/ml
Standard Deviation 0.495
|
2.85 U/ml
Standard Deviation 0.778
|
3.30 U/ml
Standard Deviation 0.990
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 7
Change at Day 7
|
0.75 U/ml
Standard Deviation 0.071
|
0.00 U/ml
Standard Deviation 0.000
|
0.85 U/ml
Standard Deviation 1.344
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Day 8Population: 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.
Baseline is defined as Day 1 pre-dose.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=2 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 8
Baseline (Day 1 pre-dose)
|
2.15 U/ml
Standard Deviation 0.495
|
2.85 U/ml
Standard Deviation 0.778
|
3.30 U/ml
Standard Deviation 0.990
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 8
Change at Day 8
|
0.70 U/ml
Standard Deviation 0.141
|
0.10 U/ml
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
1.50 U/ml
Standard Deviation 1.838
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Day 10Population: The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Baseline is defined as Day 1 pre-dose.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=2 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 10
Baseline (Day 1 pre-dose)
|
2.15 U/ml
Standard Deviation 0.495
|
2.85 U/ml
Standard Deviation 0.778
|
3.30 U/ml
Standard Deviation 0.990
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 10
Change at Day 10
|
1.85 U/ml
Standard Deviation 0.778
|
1.00 U/ml
Standard Deviation 1.273
|
1.25 U/ml
Standard Deviation 1.485
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Day 14Population: The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Baseline is defined as Day 1 pre-dose.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=2 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 14
Baseline (Day 1 pre-dose)
|
2.15 U/ml
Standard Deviation 0.495
|
2.85 U/ml
Standard Deviation 0.778
|
3.30 U/ml
Standard Deviation 0.990
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 14
Change at Day 14
|
0.90 U/ml
Standard Deviation 0.141
|
1.65 U/ml
Standard Deviation 0.495
|
1.30 U/ml
Standard Deviation 1.273
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Day 38Population: 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.
Baseline is defined as Day 1 pre-dose.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=2 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 38
Baseline (Day 1 pre-dose)
|
2.15 U/ml
Standard Deviation 0.495
|
2.85 U/ml
Standard Deviation 0.778
|
3.30 U/ml
Standard Deviation 0.990
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 38
Change at Day 38
|
0.30 U/ml
Standard Deviation NA
Standard deviation could not be calculated since only 1 participant was available for analysis.
|
1.50 U/ml
Standard Deviation 1.273
|
1.00 U/ml
Standard Deviation 1.980
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Day 60Population: The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Baseline is defined as Day 1 pre-dose.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=2 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 60
Baseline (Day 1 pre-dose)
|
2.15 U/ml
Standard Deviation 0.495
|
2.85 U/ml
Standard Deviation 0.778
|
3.30 U/ml
Standard Deviation 0.990
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C1q Binding at Day 60
Change at Day 60
|
0.65 U/ml
Standard Deviation 0.354
|
1.15 U/ml
Standard Deviation 1.061
|
1.10 U/ml
Standard Deviation 1.838
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and 15 minutes (min) post-dose on Day 1Population: The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Baseline was defined as Day 1 Pre-dose.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=2 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 15 Minutes Post-dose on Day 1
Baseline (Day 1 pre-dose): C3a level
|
32.25 nanogram per milliliter (ng/mL)
Standard Deviation 23.264
|
16.15 nanogram per milliliter (ng/mL)
Standard Deviation 0.636
|
18.65 nanogram per milliliter (ng/mL)
Standard Deviation 17.041
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 15 Minutes Post-dose on Day 1
Change at 15 min post-dose on Day 1: C3a level
|
45.40 nanogram per milliliter (ng/mL)
Standard Deviation 43.841
|
134.90 nanogram per milliliter (ng/mL)
Standard Deviation 104.369
|
46.25 nanogram per milliliter (ng/mL)
Standard Deviation 13.930
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 15 Minutes Post-dose on Day 1
Baseline (Day 1 pre-dose): SC5B-9 level
|
109.5 nanogram per milliliter (ng/mL)
Standard Deviation 17.68
|
95.5 nanogram per milliliter (ng/mL)
Standard Deviation 33.23
|
112.0 nanogram per milliliter (ng/mL)
Standard Deviation 33.94
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 15 Minutes Post-dose on Day 1
Change at 15 min post-dose on Day 1: SC5B-9 level
|
59.0 nanogram per milliliter (ng/mL)
Standard Deviation 49.50
|
196.0 nanogram per milliliter (ng/mL)
Standard Deviation 193.75
|
130.5 nanogram per milliliter (ng/mL)
Standard Deviation 33.23
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and 30 min post-dose on Day 1Population: The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Baseline was defined as Day 1 Pre-dose.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=2 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 30 Minutes Post-dose on Day 1
Baseline (Day 1 pre-dose): C3a level
|
32.25 ng/mL
Standard Deviation 23.264
|
16.15 ng/mL
Standard Deviation 0.636
|
18.65 ng/mL
Standard Deviation 17.041
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 30 Minutes Post-dose on Day 1
Change at 30 min post-dose on Day 1: C3a level
|
87.50 ng/mL
Standard Deviation 56.569
|
144.00 ng/mL
Standard Deviation 11.455
|
65.65 ng/mL
Standard Deviation 34.719
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 30 Minutes Post-dose on Day 1
Baseline (Day 1 pre-dose): SC5B-9 level
|
109.5 ng/mL
Standard Deviation 17.68
|
95.5 ng/mL
Standard Deviation 33.23
|
112.0 ng/mL
Standard Deviation 33.94
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at 30 Minutes Post-dose on Day 1
Change at 30 min post-dose on Day 1: SC5B-9 level
|
179.0 ng/mL
Standard Deviation 2.83
|
307.0 ng/mL
Standard Deviation 41.01
|
293.0 ng/mL
Standard Deviation 185.26
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline (Day 1 pre-dose) and Day 2Population: The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Baseline was defined as Day 1 Pre-dose.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=2 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at Day 2
Baseline (Day 1 pre-dose): C3a level
|
32.25 ng/mL
Standard Deviation 23.264
|
16.15 ng/mL
Standard Deviation 0.636
|
18.65 ng/mL
Standard Deviation 17.041
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at Day 2
Change at Day 2: C3a level
|
-6.55 ng/mL
Standard Deviation 12.092
|
0.90 ng/mL
Standard Deviation 0.990
|
-6.70 ng/mL
Standard Deviation 20.789
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at Day 2
Baseline (Day 1 pre-dose): SC5B-9 level
|
109.5 ng/mL
Standard Deviation 17.68
|
95.5 ng/mL
Standard Deviation 33.23
|
112.0 ng/mL
Standard Deviation 33.94
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part B: Change From Baseline (Day 1 Pre-dose) in C3a and SC5B-9 Levels at Day 2
Change at Day 2: SC5B-9 level
|
26.0 ng/mL
Standard Deviation 14.14
|
-12.5 ng/mL
Standard Deviation 36.06
|
2.0 ng/mL
Standard Deviation 22.63
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 60Population: The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=3 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=3 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=3 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
n=4 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
n=2 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
n=2 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
n=2 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Hematology, Serum Chemistry, Coagulation, and Urinalysis
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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 14Population: The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=3 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=4 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=2 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=2 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=2 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
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
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From Day 1 up to Day 60Population: The safety population, included all participants who signed the study-specific informed consent document and received at least 1 dose of TIMP-GLIA.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=3 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=3 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=3 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
n=4 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
n=2 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
n=2 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
n=2 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 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-dosePopulation: 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.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=3 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=3 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=3 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=3 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
n=2 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
n=2 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
n=2 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration For TIMP-GLIA
Day 1
|
91.8 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 48.4
|
220 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 3.0
|
457 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 17.6
|
845 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 23.6
|
—
|
252 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 6.7
|
529 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 22.6
|
938 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 2.9
|
—
|
|
Cmax: Maximum Observed Plasma Concentration For TIMP-GLIA
Day 8
|
—
|
—
|
—
|
—
|
—
|
NA nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation NA
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%.
|
408 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 26.8
|
735 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 11.7
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: 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.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=3 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=3 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=3 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=3 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
n=2 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
n=2 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
n=2 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Clast: Last Measurable Observed Plasma Concentration For TIMP-GLIA
Day 1
|
50.6 ng/mL
Geometric Coefficient of Variation 12.2
|
63.9 ng/mL
Geometric Coefficient of Variation 29.2
|
68.6 ng/mL
Geometric Coefficient of Variation 27.2
|
55.8 ng/mL
Geometric Coefficient of Variation 30.2
|
77.2 ng/mL
Geometric Coefficient of Variation 23.7
|
97.9 ng/mL
Geometric Coefficient of Variation 85.1
|
47.9 ng/mL
Geometric Coefficient of Variation 19.0
|
111 ng/mL
Geometric Coefficient of Variation 5.7
|
—
|
|
Clast: Last Measurable Observed Plasma Concentration For TIMP-GLIA
Day 8
|
—
|
—
|
—
|
—
|
—
|
NA ng/mL
Geometric Coefficient of Variation NA
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%.
|
133 ng/mL
Geometric Coefficient of Variation 137.7
|
54.4 ng/mL
Geometric Coefficient of Variation 19.5
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: 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.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=3 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=3 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=3 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=3 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
n=2 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
n=2 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
n=2 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TIMP-GLIA
Day 1
|
0.54 hour
Interval 0.5 to 0.58
|
0.50 hour
Interval 0.5 to 0.58
|
0.50 hour
Interval 0.5 to 0.58
|
0.50 hour
Interval 0.5 to 0.58
|
—
|
2.86 hour
Interval 2.85 to 2.87
|
3.21 hour
Interval 2.82 to 3.6
|
2.94 hour
Interval 2.83 to 3.05
|
—
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TIMP-GLIA
Day 8
|
—
|
—
|
—
|
—
|
—
|
NA hour
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%.
|
3.08 hour
Interval 2.82 to 3.33
|
2.90 hour
Interval 2.8 to 3.0
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: 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.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=3 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=3 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=3 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=3 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
n=2 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
n=2 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
n=2 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TIMP-GLIA
Day 1
|
—
|
604 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 3.4
|
3100 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 27.0
|
3170 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 22.8
|
8430 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 48.9
|
NA hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
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%.
|
3220 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 31.5
|
5080 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 9.2
|
—
|
|
AUCinf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TIMP-GLIA
Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
NA hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation NA
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%.
|
3250 hour*nanogram per milliliter (h*ng/mL)
Geometric Coefficient of Variation 15.1
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: 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.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=3 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=3 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=3 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=3 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
n=2 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
n=2 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
n=2 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TIMP-GLIA
Day 1
|
119 h*ng/mL
Geometric Coefficient of Variation 210.7
|
503 h*ng/mL
Geometric Coefficient of Variation 12.1
|
1690 h*ng/mL
Geometric Coefficient of Variation 88.1
|
2920 h*ng/mL
Geometric Coefficient of Variation 21.6
|
2870 h*ng/mL
Geometric Coefficient of Variation 501.3
|
932 h*ng/mL
Geometric Coefficient of Variation 65.2
|
2930 h*ng/mL
Geometric Coefficient of Variation 30.6
|
4590 h*ng/mL
Geometric Coefficient of Variation 9.6
|
—
|
|
AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TIMP-GLIA
Day 8
|
—
|
—
|
—
|
—
|
—
|
NA h*ng/mL
Geometric Coefficient of Variation NA
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%.
|
1410 h*ng/mL
Geometric Coefficient of Variation 107.1
|
3050 h*ng/mL
Geometric Coefficient of Variation 14.7
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: 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.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=3 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=3 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=3 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=3 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
n=2 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
n=2 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
n=2 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Tlast: Time to Reach the Last Measurable Plasma Concentration for TIMP-GLIA
Day 1
|
2.49 hour
Interval 1.0 to 3.98
|
4.00 hour
Interval 4.0 to 4.0
|
12.17 hour
Interval 4.0 to 24.0
|
12.00 hour
Interval 12.0 to 12.17
|
12.00 hour
Interval 4.02 to 24.53
|
7.99 hour
Interval 4.0 to 11.98
|
18.10 hour
Interval 12.2 to 24.0
|
12.00 hour
Interval 12.0 to 12.0
|
—
|
|
Tlast: Time to Reach the Last Measurable Plasma Concentration for TIMP-GLIA
Day 8
|
—
|
—
|
—
|
—
|
—
|
NA hour
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%.
|
8.01 hour
Interval 4.02 to 12.0
|
12.08 hour
Interval 12.0 to 12.15
|
—
|
SECONDARY outcome
Timeframe: 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-dosePopulation: 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.
Outcome measures
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 Participants
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=3 Participants
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=3 Participants
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=3 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=3 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
n=2 Participants
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
n=2 Participants
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
n=2 Participants
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
T1/2: Terminal Phase Elimination Half-life (T1/2) for TIMP-GLIA
Day 8
|
—
|
—
|
—
|
—
|
—
|
—
|
NA hour
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%.
|
2.51 hour
Interval 2.46 to 2.56
|
—
|
|
T1/2: Terminal Phase Elimination Half-life (T1/2) for TIMP-GLIA
Day 1
|
NA hour
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%.
|
1.81 hour
Interval 1.63 to 2.57
|
4.38 hour
Interval 1.92 to 8.24
|
3.03 hour
Interval 2.86 to 3.35
|
4.36 hour
Interval 2.72 to 6.0
|
NA hour
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%.
|
4.60 hour
Interval 2.77 to 6.43
|
3.03 hour
Interval 3.02 to 3.04
|
—
|
Adverse Events
Part A, Cohort 1: 0.1 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part A, Cohort 2: 0.5 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A, Cohort 3: 1.0 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A, Cohort 4: 2.0 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A, Cohort 5: 4.0 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A, Cohort 6: 8.0 mg/kg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part B, Cohort 1: 2.0 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B, Cohort 2: 4.0 mg/kg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Part B, Cohort 3: 8.0 mg/kg
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A, Cohort 1: 0.1 mg/kg
n=2 participants at risk
TIMP-GLIA 0.1 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 2: 0.5 mg/kg
n=2 participants at risk
TIMP-GLIA 0.5 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 3: 1.0 mg/kg
n=3 participants at risk
TIMP-GLIA 1.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 4: 2.0 mg/kg
n=3 participants at risk
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 5: 4.0 mg/kg
n=3 participants at risk
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part A, Cohort 6: 8.0 mg/kg
n=4 participants at risk
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Day 1.
|
Part B, Cohort 1: 2.0 mg/kg
n=2 participants at risk
TIMP-GLIA 2.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 2: 4.0 mg/kg
n=2 participants at risk
TIMP-GLIA 4.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
Part B, Cohort 3: 8.0 mg/kg
n=2 participants at risk
TIMP-GLIA 8.0 mg/kg, infusion, intravenously, once on Days 1 and 8.
|
|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
25.0%
1/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Eye disorders
Visual impairment
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
25.0%
1/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
25.0%
1/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
66.7%
2/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
25.0%
1/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Gastrointestinal disorders
Tongue geographic
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
25.0%
1/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
25.0%
1/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
General disorders
Chills
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
General disorders
Cyst
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
General disorders
Fatigue
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
General disorders
Medical device site erythema
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
25.0%
1/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
50.0%
1/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
25.0%
1/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
50.0%
1/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
50.0%
1/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Investigations
Fibrin D dimer increased
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
25.0%
1/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Metabolism and nutrition disorders
Gluten sensitivity
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
50.0%
1/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
50.0%
1/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
50.0%
2/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
50.0%
1/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
50.0%
1/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
50.0%
1/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
25.0%
1/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
50.0%
1/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
50.0%
1/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
50.0%
1/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
50.0%
1/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Nervous system disorders
Paraesthesia
|
50.0%
1/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
50.0%
1/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
50.0%
1/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
50.0%
1/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
33.3%
1/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
50.0%
2/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/3 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
25.0%
1/4 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
0.00%
0/2 • TEAEs are adverse events that started after the first dose of study drug up to Day 180
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER