Trial Outcomes & Findings for Single-Dose Study of MT203 (NCT NCT02354599)
NCT ID: NCT02354599
Last Updated: 2016-06-20
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Baseline up to Day 85
Results posted on
2016-06-20
Participant Flow
Participant took part in the study at 1 investigative site in Japan from 25-November-2014 to 20-May-2015.
Healthy Japanese and Caucasian participants were enrolled in the study as 1 of the 4 cohorts Japanese participants in Cohort 1(MT203 80 milligram \[mg\]), Cohort 2 (MT203 150 mg), Cohort 3 (MT203 300 mg) and Caucasian participants in Cohort 4 (MT203 150 mg) to receive MT203, or matching placebo.
Participant milestones
| Measure |
Cohort 1-3: Placebo
MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 1: MT203 80 mg
MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 2: MT203 150 mg
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 3: MT203 300 mg
MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 4: Placebo
MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Cohort 4: MT203 150 mg
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
2
|
6
|
|
Overall Study
COMPLETED
|
5
|
5
|
6
|
6
|
2
|
5
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1-3: Placebo
MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 1: MT203 80 mg
MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 2: MT203 150 mg
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 3: MT203 300 mg
MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 4: Placebo
MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Cohort 4: MT203 150 mg
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
|---|---|---|---|---|---|---|
|
Overall Study
Pretreatment Event/Adverse Event
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Single-Dose Study of MT203
Baseline characteristics by cohort
| Measure |
Cohort 1-3: Placebo
n=6 Participants
MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 1: MT203 80 mg
n=6 Participants
MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 2: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 3: MT203 300 mg
n=6 Participants
MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 4: Placebo
n=2 Participants
MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Cohort 4: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.2 years
STANDARD_DEVIATION 8.89 • n=5 Participants
|
26.0 years
STANDARD_DEVIATION 4.05 • n=7 Participants
|
26.5 years
STANDARD_DEVIATION 7.79 • n=5 Participants
|
24.2 years
STANDARD_DEVIATION 6.85 • n=4 Participants
|
28.0 years
STANDARD_DEVIATION 7.07 • n=21 Participants
|
36.0 years
STANDARD_DEVIATION 6.29 • n=10 Participants
|
28.2 years
STANDARD_DEVIATION 7.56 • n=115 Participants
|
|
Sex/Gender, Customized
Male
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
2 participants
n=21 Participants
|
6 participants
n=10 Participants
|
32 participants
n=115 Participants
|
|
Smoking Classification
Never Smoked
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
5 participants
n=10 Participants
|
21 participants
n=115 Participants
|
|
Smoking Classification
Ex-smoker
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
4 participants
n=4 Participants
|
0 participants
n=21 Participants
|
1 participants
n=10 Participants
|
11 participants
n=115 Participants
|
|
Alcohol Classification
Drank a few days per week
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=10 Participants
|
6 participants
n=115 Participants
|
|
Alcohol Classification
Drank a few days per month
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
3 participants
n=4 Participants
|
2 participants
n=21 Participants
|
2 participants
n=10 Participants
|
12 participants
n=115 Participants
|
|
Alcohol Classification
Never drank
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
2 participants
n=10 Participants
|
14 participants
n=115 Participants
|
|
Caffeine Classification
Had caffeine consumption
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
3 participants
n=10 Participants
|
13 participants
n=115 Participants
|
|
Caffeine Classification
Had no caffeine consumption
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
4 participants
n=4 Participants
|
0 participants
n=21 Participants
|
3 participants
n=10 Participants
|
19 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 85Population: The safety analysis set was defined as all participants who received the study medication.
Outcome measures
| Measure |
Cohort 1-3: Placebo
n=6 Participants
MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 1: MT203 80 mg
n=6 Participants
MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 2: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 3: MT203 300 mg
n=6 Participants
MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 4: Placebo
n=2 Participants
MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Cohort 4: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)
|
3 participants
|
3 participants
|
1 participants
|
1 participants
|
1 participants
|
5 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 85Population: The safety analysis set was defined as all participants who received the study medication.
Outcome measures
| Measure |
Cohort 1-3: Placebo
n=6 Participants
MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 1: MT203 80 mg
n=6 Participants
MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 2: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 3: MT203 300 mg
n=6 Participants
MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 4: Placebo
n=2 Participants
MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Cohort 4: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs Related to Vital Signs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 85Population: The safety analysis set was defined as all participants who received the study medication.
Outcome measures
| Measure |
Cohort 1-3: Placebo
n=6 Participants
MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 1: MT203 80 mg
n=6 Participants
MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 2: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 3: MT203 300 mg
n=6 Participants
MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 4: Placebo
n=2 Participants
MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Cohort 4: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs Related to Body Weight
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 85Population: The safety analysis set was defined as all participants who received the study medication.
Outcome measures
| Measure |
Cohort 1-3: Placebo
n=6 Participants
MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 1: MT203 80 mg
n=6 Participants
MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 2: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 3: MT203 300 mg
n=6 Participants
MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 4: Placebo
n=2 Participants
MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Cohort 4: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs Related to 12-lead Electrocardiograms (ECG)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 85Population: The safety analysis set was defined as all participants who received the study medication.
Outcome measures
| Measure |
Cohort 1-3: Placebo
n=6 Participants
MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 1: MT203 80 mg
n=6 Participants
MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 2: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 3: MT203 300 mg
n=6 Participants
MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 4: Placebo
n=2 Participants
MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Cohort 4: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs Related to Lung Functioning Monitoring
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Day 85Population: The safety analysis set was defined as all participants who received the study medication.
Outcome measures
| Measure |
Cohort 1-3: Placebo
n=6 Participants
MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 1: MT203 80 mg
n=6 Participants
MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 2: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 3: MT203 300 mg
n=6 Participants
MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 4: Placebo
n=2 Participants
MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Cohort 4: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
|---|---|---|---|---|---|---|
|
Number of Participants With TEAEs Related to Hematology, Serum Chemistry and Urinalysis
Hematology
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With TEAEs Related to Hematology, Serum Chemistry and Urinalysis
Serum Chemistry
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With TEAEs Related to Hematology, Serum Chemistry and Urinalysis
Urinalysis
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Predose and at multiple time points (up to 84 days) post-dosePopulation: The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.
Outcome measures
| Measure |
Cohort 1-3: Placebo
n=6 Participants
MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 1: MT203 80 mg
n=6 Participants
MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 2: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 3: MT203 300 mg
n=6 Participants
MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 4: Placebo
MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Cohort 4: MT203 150 mg
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve From Time 0 to Infinity (AUC(0-inf)) of MT203
|
315573.3 nanogram*day per milliliter (ng*day/mL)
Standard Deviation 47464.44
|
575180.7 nanogram*day per milliliter (ng*day/mL)
Standard Deviation 126751.71
|
1238496.3 nanogram*day per milliliter (ng*day/mL)
Standard Deviation 222651.06
|
559689.3 nanogram*day per milliliter (ng*day/mL)
Standard Deviation 188835.67
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and at multiple time points (up to 84 days) post-dosePopulation: The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.
Outcome measures
| Measure |
Cohort 1-3: Placebo
n=6 Participants
MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 1: MT203 80 mg
n=6 Participants
MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 2: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 3: MT203 300 mg
n=6 Participants
MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 4: Placebo
MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Cohort 4: MT203 150 mg
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
|---|---|---|---|---|---|---|
|
Area Under the Serum Concentration-Time Curve From Time 0 to Time 84 Days (AUC(0-84d)) of MT203
|
286383.2 ng*day/mL
Standard Deviation 44732.15
|
502017.5 ng*day/mL
Standard Deviation 116382.43
|
1106605.2 ng*day/mL
Standard Deviation 207794.23
|
451596.7 ng*day/mL
Standard Deviation 133571.47
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and at multiple time points (up to Day 84) post-dosePopulation: The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.
Outcome measures
| Measure |
Cohort 1-3: Placebo
n=6 Participants
MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 1: MT203 80 mg
n=6 Participants
MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 2: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 3: MT203 300 mg
n=6 Participants
MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 4: Placebo
MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Cohort 4: MT203 150 mg
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
|---|---|---|---|---|---|---|
|
Maximum Observed Serum Concentrations (Cmax) of MT203
|
8381.3 nanogram per milliliter (ng/mL)
Standard Deviation 1848.65
|
15354.5 nanogram per milliliter (ng/mL)
Standard Deviation 5097.64
|
32580.7 nanogram per milliliter (ng/mL)
Standard Deviation 9061.85
|
10826.7 nanogram per milliliter (ng/mL)
Standard Deviation 3220.93
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose and at multiple time points (up to 84 days) post-dosePopulation: The pharmacokinetic analysis set as defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacokinetic data.
Outcome measures
| Measure |
Cohort 1-3: Placebo
n=6 Participants
MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 1: MT203 80 mg
n=6 Participants
MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 2: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 3: MT203 300 mg
n=6 Participants
MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 4: Placebo
MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Cohort 4: MT203 150 mg
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
|---|---|---|---|---|---|---|
|
Terminal Elimination Half-Life (T1/2) of MT203
|
23.75 day
Interval 22.3 to 25.7
|
26.20 day
Interval 22.6 to 43.0
|
26.15 day
Interval 22.7 to 31.1
|
32.60 day
Interval 25.2 to 44.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Hour 24, 72, 120, 168, 240, 336 hours, Day 21, 28, 42, 56, 70, 84Population: The pharmacodynamic analysis set was defined as all participants who received the study medication without any major protocol deviations, and met the minimum procedure specified in the study protocol and had evaluable pharmacodynamic data.
Outcome measures
| Measure |
Cohort 1-3: Placebo
n=6 Participants
MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 1: MT203 80 mg
n=6 Participants
MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 2: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 3: MT203 300 mg
n=6 Participants
MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 4: Placebo
n=6 Participants
MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Cohort 4: MT203 150 mg
n=2 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
|---|---|---|---|---|---|---|
|
Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration
Baseline
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
|
Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration
24 Hours
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
9.123 picogram per milliliter (pg/mL)
Standard Deviation 22.3475
|
14.857 picogram per milliliter (pg/mL)
Standard Deviation 23.0308
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
|
Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration
72 Hours
|
123.535 picogram per milliliter (pg/mL)
Standard Deviation 20.4004
|
131.165 picogram per milliliter (pg/mL)
Standard Deviation 25.2255
|
155.707 picogram per milliliter (pg/mL)
Standard Deviation 37.5200
|
134.788 picogram per milliliter (pg/mL)
Standard Deviation 39.9181
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
|
Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration
120 Hours
|
215.698 picogram per milliliter (pg/mL)
Standard Deviation 33.8697
|
233.063 picogram per milliliter (pg/mL)
Standard Deviation 46.0860
|
277.878 picogram per milliliter (pg/mL)
Standard Deviation 57.0774
|
248.055 picogram per milliliter (pg/mL)
Standard Deviation 79.1963
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
|
Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration
168 Hours
|
291.852 picogram per milliliter (pg/mL)
Standard Deviation 48.4269
|
314.218 picogram per milliliter (pg/mL)
Standard Deviation 65.0007
|
375.772 picogram per milliliter (pg/mL)
Standard Deviation 72.3014
|
361.720 picogram per milliliter (pg/mL)
Standard Deviation 113.4442
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
|
Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration
240 Hours
|
387.628 picogram per milliliter (pg/mL)
Standard Deviation 60.4318
|
415.098 picogram per milliliter (pg/mL)
Standard Deviation 88.4198
|
489.127 picogram per milliliter (pg/mL)
Standard Deviation 72.4588
|
493.835 picogram per milliliter (pg/mL)
Standard Deviation 113.3446
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
|
Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration
336 Hours
|
483.353 picogram per milliliter (pg/mL)
Standard Deviation 77.2963
|
554.973 picogram per milliliter (pg/mL)
Standard Deviation 122.5254
|
675.010 picogram per milliliter (pg/mL)
Standard Deviation 96.1891
|
565.527 picogram per milliliter (pg/mL)
Standard Deviation 137.2089
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
|
Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration
21 Days
|
733.440 picogram per milliliter (pg/mL)
Standard Deviation 330.8767
|
710.998 picogram per milliliter (pg/mL)
Standard Deviation 202.6718
|
859.977 picogram per milliliter (pg/mL)
Standard Deviation 160.9109
|
677.693 picogram per milliliter (pg/mL)
Standard Deviation 194.5259
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
|
Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration
28 Days
|
653.467 picogram per milliliter (pg/mL)
Standard Deviation 111.0059
|
758.195 picogram per milliliter (pg/mL)
Standard Deviation 157.6988
|
951.438 picogram per milliliter (pg/mL)
Standard Deviation 207.3810
|
781.040 picogram per milliliter (pg/mL)
Standard Deviation 167.7037
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
|
Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration
42 Days
|
547.093 picogram per milliliter (pg/mL)
Standard Deviation 81.0675
|
740.245 picogram per milliliter (pg/mL)
Standard Deviation 245.6498
|
807.632 picogram per milliliter (pg/mL)
Standard Deviation 193.1090
|
828.695 picogram per milliliter (pg/mL)
Standard Deviation 271.3573
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
|
Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration
56 Days
|
431.300 picogram per milliliter (pg/mL)
Standard Deviation 94.4867
|
633.093 picogram per milliliter (pg/mL)
Standard Deviation 186.5863
|
758.747 picogram per milliliter (pg/mL)
Standard Deviation 238.7338
|
617.653 picogram per milliliter (pg/mL)
Standard Deviation 192.0337
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
|
Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration
70 Days
|
325.750 picogram per milliliter (pg/mL)
Standard Deviation 67.8796
|
440.092 picogram per milliliter (pg/mL)
Standard Deviation 126.7378
|
668.387 picogram per milliliter (pg/mL)
Standard Deviation 181.7359
|
467.965 picogram per milliliter (pg/mL)
Standard Deviation 173.5354
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
|
Plasma Total Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) Concentration
84 Days
|
240.712 picogram per milliliter (pg/mL)
Standard Deviation 44.5704
|
366.078 picogram per milliliter (pg/mL)
Standard Deviation 200.2973
|
545.100 picogram per milliliter (pg/mL)
Standard Deviation 151.8562
|
379.647 picogram per milliliter (pg/mL)
Standard Deviation 189.7192
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
0.000 picogram per milliliter (pg/mL)
Standard Deviation 0.0000
|
SECONDARY outcome
Timeframe: Baseline, Hour 168, 336, Day 42, 84Population: The safety analysis set was defined as all participants who received the study medication.
Outcome measures
| Measure |
Cohort 1-3: Placebo
n=6 Participants
MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 1: MT203 80 mg
n=6 Participants
MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 2: MT203 150 mg
n=6 Participants
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 3: MT203 300 mg
n=6 Participants
MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 4: Placebo
MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Cohort 4: MT203 150 mg
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Positive Response for Anti MT203 Antibody
Baseline
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
—
|
|
Number of Participants With Positive Response for Anti MT203 Antibody
168 Hours
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
—
|
—
|
|
Number of Participants With Positive Response for Anti MT203 Antibody
336 Hours
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
—
|
—
|
|
Number of Participants With Positive Response for Anti MT203 Antibody
42 Days
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
—
|
—
|
|
Number of Participants With Positive Response for Anti MT203 Antibody
84 Days
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
—
|
—
|
Adverse Events
Cohort 1-3: Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 1: MT203 80 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2: MT203 150 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 3: MT203 300 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Cohort 4: MT203 150 mg
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1-3: Placebo
n=6 participants at risk
MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 1: MT203 80 mg
n=6 participants at risk
MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 2: MT203 150 mg
n=6 participants at risk
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 3: MT203 300 mg
n=6 participants at risk
MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 4: Placebo
n=2 participants at risk
MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Cohort 4: MT203 150 mg
n=6 participants at risk
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Retinal detachment
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Cohort 1-3: Placebo
n=6 participants at risk
MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 1: MT203 80 mg
n=6 participants at risk
MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 2: MT203 150 mg
n=6 participants at risk
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 3: MT203 300 mg
n=6 participants at risk
MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
|
Cohort 4: Placebo
n=2 participants at risk
MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
Cohort 4: MT203 150 mg
n=6 participants at risk
MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and 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
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and 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
Pyrexia
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and 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
Influenza
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and 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 urine present
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and 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
Forced vital capacity decreased
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and 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
Protein urine present
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and 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
Muscular weakness
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and 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
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and 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
Rhinorrhoea
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and 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
Erythema
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and 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
Pruritus
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. 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 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
16.7%
1/6 • Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug on Day 1 up to Day 85
At each visit the investigator had to document any occurrence of adverse events and 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