Trial Outcomes & Findings for A Study of Mirikizumab in Healthy Chinese Participants (NCT NCT04137380)
NCT ID: NCT04137380
Last Updated: 2024-01-26
Results Overview
Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of serious adverse events (SAEs) and other non-serious adverse events (NSAEs), regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Baseline through Day 85
Results posted on
2024-01-26
Participant Flow
Participant milestones
| Measure |
Placebo Intravenous (IV)
Participants received a single dose of placebo administered IV using a forearm vein.
|
300 Milligram (mg) Mirikizumab IV
Participants received a single dose of 300 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes.
|
600 mg Mirikizumab IV
Participants received a single dose of 600 mg mirikizumab administered IV using a forearm vein infused over at least 60 minutes.
|
1200 mg Mirikizumab IV
Participants received a single dose of 1200 mg mirikizumab administered IV using a forearm vein infused over at least 2 hours.
|
Placebo Subcutaneous (SC)
Participants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
200 mg Mirikizumab SC
Participants received a single dose of 200 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
400 mg Mirikizumab SC
Participants received a single dose of 400 mg mirikizumab administered SC as 4 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
10
|
10
|
10
|
4
|
10
|
10
|
|
Overall Study
Received at Least One Dose of Study Drug
|
6
|
10
|
10
|
10
|
4
|
10
|
10
|
|
Overall Study
COMPLETED
|
6
|
10
|
10
|
9
|
4
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo Intravenous (IV)
Participants received a single dose of placebo administered IV using a forearm vein.
|
300 Milligram (mg) Mirikizumab IV
Participants received a single dose of 300 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes.
|
600 mg Mirikizumab IV
Participants received a single dose of 600 mg mirikizumab administered IV using a forearm vein infused over at least 60 minutes.
|
1200 mg Mirikizumab IV
Participants received a single dose of 1200 mg mirikizumab administered IV using a forearm vein infused over at least 2 hours.
|
Placebo Subcutaneous (SC)
Participants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
200 mg Mirikizumab SC
Participants received a single dose of 200 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
400 mg Mirikizumab SC
Participants received a single dose of 400 mg mirikizumab administered SC as 4 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of Mirikizumab in Healthy Chinese Participants
Baseline characteristics by cohort
| Measure |
Placebo IV
n=6 Participants
Participants received a single dose of placebo administered IV using a forearm vein.
|
300 mg Mirikizumab IV
n=10 Participants
Participants received a single dose of 300 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes.
|
600 mg Mirikizumab IV
n=10 Participants
Participants received a single dose of 600 mg mirikizumab administered IV using a forearm vein infused over at least 60 minutes.
|
1200 mg Mirikizumab IV
n=10 Participants
Participants received a single dose of 1200 mg mirikizumab administered IV using a forearm vein infused over at least 2 hours.
|
Placebo SC
n=4 Participants
Participants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
200 mg Mirikizumab SC
n=10 Participants
Participants received a single dose of 200 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
400 mg Mirikizumab SC
n=10 Participants
Participants received a single dose of 400 mg mirikizumab administered SC as 4 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
26.0 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 6.4 • n=7 Participants
|
31.7 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
36.5 years
STANDARD_DEVIATION 6.1 • n=4 Participants
|
25.0 years
STANDARD_DEVIATION 5.0 • n=21 Participants
|
33.9 years
STANDARD_DEVIATION 7.2 • n=8 Participants
|
31.8 years
STANDARD_DEVIATION 6.2 • n=8 Participants
|
32.0 years
STANDARD_DEVIATION 6.8 • n=24 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
23 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
37 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
60 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
60 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
China
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
60 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 85Population: All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of serious adverse events (SAEs) and other non-serious adverse events (NSAEs), regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.
Outcome measures
| Measure |
Placebo IV
n=6 Participants
Participants received a single dose of placebo administered IV using a forearm vein.
|
300 mg Mirikizumab IV
n=10 Participants
Participants received a single dose of 300 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes.
|
600 mg Mirikizumab IV
n=10 Participants
Participants received a single dose of 600 mg mirikizumab administered IV using a forearm vein infused over at least 60 minutes.
|
1200 mg Mirikizumab IV
n=10 Participants
Participants received a single dose of 1200 mg mirikizumab administered IV using a forearm vein infused over at least 2 hours.
|
Placebo SC
n=4 Participants
Participants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
200 mg Mirikizumab SC
n=10 Participants
Participants received a single dose of 200 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
400 mg Mirikizumab SC
n=10 Participants
Participants received a single dose of 400 mg mirikizumab administered SC as 4 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Drug-Related Treatment-Emergent Adverse Events (TEAEs)
|
1 participants
|
3 participants
|
4 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: 0 min, 0.25 hours (h), 0.5 h, 1 h, 2 h and 4 h post first injectionPopulation: All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment. As per statistical analysis plan, VAS pain score was analyzed only for SC dose.
The injection pain VAS score is a participant administered single item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. The severity of pain was categorized by VAS pain score as: no pain (0), mild pain ≤ 30, moderate pain (\>30 and ≤70), and severe pain (\>70). Overall severity of participant's pain is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no pain) to 100 mm (worst imaginable pain).
Outcome measures
| Measure |
Placebo IV
n=4 Participants
Participants received a single dose of placebo administered IV using a forearm vein.
|
300 mg Mirikizumab IV
n=10 Participants
Participants received a single dose of 300 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes.
|
600 mg Mirikizumab IV
n=10 Participants
Participants received a single dose of 600 mg mirikizumab administered IV using a forearm vein infused over at least 60 minutes.
|
1200 mg Mirikizumab IV
Participants received a single dose of 1200 mg mirikizumab administered IV using a forearm vein infused over at least 2 hours.
|
Placebo SC
Participants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
200 mg Mirikizumab SC
Participants received a single dose of 200 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
400 mg Mirikizumab SC
Participants received a single dose of 400 mg mirikizumab administered SC as 4 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
|---|---|---|---|---|---|---|---|
|
Visual Analog Scale (VAS) Pain Score for Subcutaneous Injection Site
0 min
|
36.5 millimeter (mm)
Standard Deviation 36.3
|
30.8 millimeter (mm)
Standard Deviation 29.5
|
42.4 millimeter (mm)
Standard Deviation 26.0
|
—
|
—
|
—
|
—
|
|
Visual Analog Scale (VAS) Pain Score for Subcutaneous Injection Site
0.25 h
|
3.5 millimeter (mm)
Standard Deviation 3.3
|
2.9 millimeter (mm)
Standard Deviation 3.7
|
10.6 millimeter (mm)
Standard Deviation 20.2
|
—
|
—
|
—
|
—
|
|
Visual Analog Scale (VAS) Pain Score for Subcutaneous Injection Site
0.5 h
|
2.3 millimeter (mm)
Standard Deviation 2.6
|
1.9 millimeter (mm)
Standard Deviation 3.4
|
9.5 millimeter (mm)
Standard Deviation 23.1
|
—
|
—
|
—
|
—
|
|
Visual Analog Scale (VAS) Pain Score for Subcutaneous Injection Site
1 h
|
1.0 millimeter (mm)
Standard Deviation 0.8
|
1.6 millimeter (mm)
Standard Deviation 1.9
|
2.0 millimeter (mm)
Standard Deviation 1.8
|
—
|
—
|
—
|
—
|
|
Visual Analog Scale (VAS) Pain Score for Subcutaneous Injection Site
2 h
|
1.8 millimeter (mm)
Standard Deviation 1.0
|
1.2 millimeter (mm)
Standard Deviation 1.5
|
2.0 millimeter (mm)
Standard Deviation 2.0
|
—
|
—
|
—
|
—
|
|
Visual Analog Scale (VAS) Pain Score for Subcutaneous Injection Site
4 h
|
1.0 millimeter (mm)
Standard Deviation 0.8
|
1.0 millimeter (mm)
Standard Deviation 1.2
|
2.1 millimeter (mm)
Standard Deviation 2.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85 postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Cmax of Mirikizumab was evaluated.
Outcome measures
| Measure |
Placebo IV
n=9 Participants
Participants received a single dose of placebo administered IV using a forearm vein.
|
300 mg Mirikizumab IV
n=10 Participants
Participants received a single dose of 300 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes.
|
600 mg Mirikizumab IV
n=9 Participants
Participants received a single dose of 600 mg mirikizumab administered IV using a forearm vein infused over at least 60 minutes.
|
1200 mg Mirikizumab IV
n=10 Participants
Participants received a single dose of 1200 mg mirikizumab administered IV using a forearm vein infused over at least 2 hours.
|
Placebo SC
n=10 Participants
Participants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
200 mg Mirikizumab SC
Participants received a single dose of 200 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
400 mg Mirikizumab SC
Participants received a single dose of 400 mg mirikizumab administered SC as 4 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab
|
145 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 7
|
266 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 16
|
511 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 10
|
14.9 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 28
|
23.1 microgram per milliliter (μg/mL)
Geometric Coefficient of Variation 44
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85 postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: AUC(0-∞) of Mirikizumab was evaluated.
Outcome measures
| Measure |
Placebo IV
n=9 Participants
Participants received a single dose of placebo administered IV using a forearm vein.
|
300 mg Mirikizumab IV
n=10 Participants
Participants received a single dose of 300 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes.
|
600 mg Mirikizumab IV
n=9 Participants
Participants received a single dose of 600 mg mirikizumab administered IV using a forearm vein infused over at least 60 minutes.
|
1200 mg Mirikizumab IV
n=10 Participants
Participants received a single dose of 1200 mg mirikizumab administered IV using a forearm vein infused over at least 2 hours.
|
Placebo SC
n=10 Participants
Participants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
200 mg Mirikizumab SC
Participants received a single dose of 200 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
400 mg Mirikizumab SC
Participants received a single dose of 400 mg mirikizumab administered SC as 4 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
|---|---|---|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Mirikizumab
|
936 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 12
|
2030 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 12
|
3320 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 23
|
263 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 29
|
421 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 46
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, [end of infusion (EOI) IV only], Day 1: 6 hours (h), Day 2, Day 4, Day 8, Day 11 (SC only), Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, and Day 85 postdosePopulation: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: AUC(0-tlast) of Mirikizumab was evaluated.
Outcome measures
| Measure |
Placebo IV
n=5 Participants
Participants received a single dose of placebo administered IV using a forearm vein.
|
300 mg Mirikizumab IV
n=10 Participants
Participants received a single dose of 300 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes.
|
600 mg Mirikizumab IV
n=8 Participants
Participants received a single dose of 600 mg mirikizumab administered IV using a forearm vein infused over at least 60 minutes.
|
1200 mg Mirikizumab IV
n=7 Participants
Participants received a single dose of 1200 mg mirikizumab administered IV using a forearm vein infused over at least 2 hours.
|
Placebo SC
n=10 Participants
Participants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
200 mg Mirikizumab SC
Participants received a single dose of 200 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
400 mg Mirikizumab SC
Participants received a single dose of 400 mg mirikizumab administered SC as 4 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
|---|---|---|---|---|---|---|---|
|
PK: AUC From Time Zero to Time T, Where T is the Last Sample With a Measurable Concentration (AUC[0-tlast]) of Mirikizumab
|
964 μg*day/mL
Geometric Coefficient of Variation 15
|
2010 μg*day/mL
Geometric Coefficient of Variation 12
|
3300 μg*day/mL
Geometric Coefficient of Variation 24
|
248 μg*day/mL
Geometric Coefficient of Variation 34
|
417 μg*day/mL
Geometric Coefficient of Variation 46
|
—
|
—
|
Adverse Events
Placebo IV
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
300 mg Mirikizumab IV
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
600 mg Mirikizumab IV
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
1200 mg Mirikizumab IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo SC
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
200 mg Mirikizumab SC
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
400 mg Mirikizumab SC
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo IV
n=6 participants at risk
Participants received a single dose of placebo administered IV using a forearm vein.
|
300 mg Mirikizumab IV
n=10 participants at risk
Participants received a single dose of 300 mg mirikizumab administered IV using a forearm vein infused over at least 30 minutes.
|
600 mg Mirikizumab IV
n=10 participants at risk
Participants received a single dose of 600 mg mirikizumab administered IV using a forearm vein infused over at least 60 minutes.
|
1200 mg Mirikizumab IV
n=10 participants at risk
Participants received a single dose of 1200 mg mirikizumab administered IV using a forearm vein infused over at least 2 hours.
|
Placebo SC
n=4 participants at risk
Participants received a single dose of placebo administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
200 mg Mirikizumab SC
n=10 participants at risk
Participants received a single dose of 200 mg mirikizumab administered SC as 2 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
400 mg Mirikizumab SC
n=10 participants at risk
Participants received a single dose of 400 mg mirikizumab administered SC as 4 injections, 1 into the skinfold of each lower abdominal wall quadrant (left and right).
|
|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
16.7%
1/6 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
30.0%
3/10 • Number of events 5 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
20.0%
2/10 • Number of events 2 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
1/6 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
25.0%
1/4 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
25.0%
1/4 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 2 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
1/6 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
1/6 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
20.0%
2/10 • Number of events 2 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
25.0%
1/4 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
25.0%
1/4 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Injury, poisoning and procedural complications
Scratch
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Investigations
Alanine aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
16.7%
1/6 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
25.0%
1/4 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Investigations
Blood creatine phosphokinase increased
|
16.7%
1/6 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
20.0%
2/10 • Number of events 2 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Investigations
Blood uric acid increased
|
16.7%
1/6 • Number of events 2 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
20.0%
2/10 • Number of events 2 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
25.0%
1/4 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
20.0%
2/10 • Number of events 2 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
25.0%
1/4 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Investigations
White blood cell count abnormal
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Investigations
White blood cell count decreased
|
16.7%
1/6 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Investigations
White blood cell count increased
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 2 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Investigations
White blood cells urine positive
|
16.7%
1/6 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Reproductive system and breast disorders
Menstruation delayed
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis hypertrophic
|
0.00%
0/6 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
10.0%
1/10 • Number of events 1 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/4 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
0.00%
0/10 • Up To 85 Days
All randomized participants who received at least one dose of study drug and have at least one postdose safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 120 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER