Trial Outcomes & Findings for A Study of Mirikizumab (LY3074828) in Healthy Participants (NCT NCT02568423)
NCT ID: NCT02568423
Last Updated: 2024-02-08
Results Overview
SAE is any adverse event (AE) from this study that results in one of the following outcomes: 1. death 2. initial or prolonged inpatient hospitalization 3. a life-threatening experience (that is, immediate risk of dying) 4. persistent or significant disability/incapacity 5. congenital anomaly/birth defect 6. considered significant by the investigator for any other reason
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
51 participants
Primary outcome timeframe
Baseline through Day 85
Results posted on
2024-02-08
Participant Flow
Participant milestones
| Measure |
Placebo Subcutaneous (SC)
Participants received placebo subcutaneously (SC).
|
Placebo IV
Participants received placebo by IV.
|
60mg Mirikizumab IV
Participants received 60mg Mirikizumab by IV.
|
200mg Mirikizumab SC
Participants received 200mg Mirikizumab by SC.
|
200mg Mirikizumab IV
Participants received 200mg Mirikizumab by IV.
|
600mg Mirikizumab IV
Participants received 600mg Mirikizumab by IV.
|
1200mg Mirikizumab IV
Participants received 1200mg Mirikizumab by IV.
|
2400mg Mirikizumab IV
Participants received 2400mg Mirikizumab by IV.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
10
|
6
|
6
|
6
|
9
|
6
|
6
|
|
Overall Study
Received at Least One Dose of Study Drug
|
2
|
10
|
6
|
6
|
6
|
9
|
6
|
6
|
|
Overall Study
COMPLETED
|
2
|
8
|
6
|
6
|
6
|
8
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo Subcutaneous (SC)
Participants received placebo subcutaneously (SC).
|
Placebo IV
Participants received placebo by IV.
|
60mg Mirikizumab IV
Participants received 60mg Mirikizumab by IV.
|
200mg Mirikizumab SC
Participants received 200mg Mirikizumab by SC.
|
200mg Mirikizumab IV
Participants received 200mg Mirikizumab by IV.
|
600mg Mirikizumab IV
Participants received 600mg Mirikizumab by IV.
|
1200mg Mirikizumab IV
Participants received 1200mg Mirikizumab by IV.
|
2400mg Mirikizumab IV
Participants received 2400mg Mirikizumab by IV.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
A Study of Mirikizumab (LY3074828) in Healthy Participants
Baseline characteristics by cohort
| Measure |
Placebo SC
n=2 Participants
Participants received placebo by SC.
|
Placebo IV
n=10 Participants
Participants received placebo by IV.
|
60mg Mirikizumab IV
n=6 Participants
Participants received 60mg Mirikizumab by IV.
|
200mg Mirikizumab SC
n=6 Participants
Participants received 200mg Mirikizumab by SC.
|
200mg Mirikizumab IV
n=6 Participants
Participants received 200mg Mirikizumab by IV.
|
600mg Mirikizumab IV
n=9 Participants
Participants received 600mg Mirikizumab by IV.
|
1200mg Mirikizumab IV
n=6 Participants
Participants received 1200mg Mirikizumab by IV.
|
2400mg Mirikizumab IV
n=6 Participants
Participants received 2400mg Mirikizumab by IV.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
48.5 years
STANDARD_DEVIATION 2.1 • n=99 Participants
|
45.7 years
STANDARD_DEVIATION 10.6 • n=107 Participants
|
49.3 years
STANDARD_DEVIATION 9.4 • n=206 Participants
|
37.3 years
STANDARD_DEVIATION 8.8 • n=7 Participants
|
41.7 years
STANDARD_DEVIATION 16.0 • n=31 Participants
|
46.8 years
STANDARD_DEVIATION 11.9 • n=30 Participants
|
37.8 years
STANDARD_DEVIATION 11.9 • n=3 Participants
|
45.2 years
STANDARD_DEVIATION 6.0 • n=6 Participants
|
44 years
STANDARD_DEVIATION 11 • n=114 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
31 Participants
n=114 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
20 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
1 Participants
n=6 Participants
|
9 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
42 Participants
n=114 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
26 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
3 Participants
n=6 Participants
|
25 Participants
n=114 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=114 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
6 Participants
n=6 Participants
|
51 Participants
n=114 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 85Population: All randomized participants.
SAE is any adverse event (AE) from this study that results in one of the following outcomes: 1. death 2. initial or prolonged inpatient hospitalization 3. a life-threatening experience (that is, immediate risk of dying) 4. persistent or significant disability/incapacity 5. congenital anomaly/birth defect 6. considered significant by the investigator for any other reason
Outcome measures
| Measure |
Placebo SC
n=2 Participants
Participants received placebo by SC.
|
Placebo IV
n=10 Participants
Participants received placebo by IV.
|
60mg Mirikizumab IV
n=6 Participants
Participants received 60mg Mirikizumab by IV.
|
200mg Mirikizumab IV
n=6 Participants
Participants received 200mg Mirikizumab b IV.
|
200mg Mirikizumab SC
n=6 Participants
Participants received 200mg Mirikizumab by SC.
|
600mg Mirikizumab IV
n=9 Participants
Participants received 600mg Mirikizumab by IV.
|
1200mg Mirikizumab IV
n=6 Participants
Participants received 1200mg Mirikizumab by IV.
|
2400mg Mirikizumab IV
n=6 Participants
Participants received 2400mg Mirikizumab by IV.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administrationPopulation: All randomized participants who received at least one dose of Mirikizumab and had evaluable PK data.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab.
Outcome measures
| Measure |
Placebo SC
n=6 Participants
Participants received placebo by SC.
|
Placebo IV
n=6 Participants
Participants received placebo by IV.
|
60mg Mirikizumab IV
n=6 Participants
Participants received 60mg Mirikizumab by IV.
|
200mg Mirikizumab IV
n=8 Participants
Participants received 200mg Mirikizumab b IV.
|
200mg Mirikizumab SC
n=6 Participants
Participants received 200mg Mirikizumab by SC.
|
600mg Mirikizumab IV
n=6 Participants
Participants received 600mg Mirikizumab by IV.
|
1200mg Mirikizumab IV
Participants received 1200mg Mirikizumab by IV.
|
2400mg Mirikizumab IV
Participants received 2400mg Mirikizumab by IV.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab
|
23.1 Microgram per Milliliter (μg/mL)
Geometric Coefficient of Variation 9
|
11.8 Microgram per Milliliter (μg/mL)
Geometric Coefficient of Variation 39
|
78.8 Microgram per Milliliter (μg/mL)
Geometric Coefficient of Variation 13
|
250 Microgram per Milliliter (μg/mL)
Geometric Coefficient of Variation 16
|
454 Microgram per Milliliter (μg/mL)
Geometric Coefficient of Variation 11
|
985 Microgram per Milliliter (μg/mL)
Geometric Coefficient of Variation 20
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1: 0 (pre dose), end of infusion, 2, 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for IV administration; Day 1: 0 (pre dose), 6, 24, 72, 168, 240, 336, 504, 672, 1008, 1344, 1680, 2016 hr post dose for SC administrationPopulation: All randomized participants who received at least one dose of Mirikizumab and had evaluable PK data.
Pharmacokinetics: Area Under the Concentration (AUC) Curve from Time Zero to Infinity of Mirikizumab.
Outcome measures
| Measure |
Placebo SC
n=6 Participants
Participants received placebo by SC.
|
Placebo IV
n=6 Participants
Participants received placebo by IV.
|
60mg Mirikizumab IV
n=6 Participants
Participants received 60mg Mirikizumab by IV.
|
200mg Mirikizumab IV
n=8 Participants
Participants received 200mg Mirikizumab b IV.
|
200mg Mirikizumab SC
n=6 Participants
Participants received 200mg Mirikizumab by SC.
|
600mg Mirikizumab IV
n=6 Participants
Participants received 600mg Mirikizumab by IV.
|
1200mg Mirikizumab IV
Participants received 1200mg Mirikizumab by IV.
|
2400mg Mirikizumab IV
Participants received 2400mg Mirikizumab by IV.
|
|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration (AUC) Curve From Time Zero to Infinity of Mirikizumab
|
148 Microgram day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 29
|
210 Microgram day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 29
|
539 Microgram day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 12
|
1970 Microgram day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 24
|
2900 Microgram day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 14
|
5990 Microgram day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 12
|
—
|
—
|
Adverse Events
Placebo SC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo IV
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
60mg Mirikizumab IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
200mg Mirikizumab SC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
200mg Mirikizumab IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
600mg Mirikizumab IV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
1200mg Mirikizumab IV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
2400mg Mirikizumab IV
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo SC
n=2 participants at risk
Participants received placebo by SC.
|
Placebo IV
n=10 participants at risk
Participants received placebo by IV.
|
60mg Mirikizumab IV
n=6 participants at risk
Participants received 60mg Mirikizumab by IV.
|
200mg Mirikizumab SC
n=6 participants at risk
Participants received 200mg Mirikizumab by SC.
|
200mg Mirikizumab IV
n=6 participants at risk
Participants received 200mg Mirikizumab by IV.
|
600mg Mirikizumab IV
n=9 participants at risk
Participants received 600mg Mirikizumab by IV.
|
1200mg Mirikizumab IV
n=6 participants at risk
Participants received 1200mg Mirikizumab by IV.
|
2400mg Mirikizumab IV
n=6 participants at risk
Participants received 2400mg Mirikizumab by IV.
|
|---|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Sinus arrhythmia
|
0.00%
0/2 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/2 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/2 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
11.1%
1/9 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/2 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
1/2 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/2 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/2 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
50.0%
1/2 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
10.0%
1/10 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/10 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
16.7%
1/6 • Number of events 1 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/9 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Up to 88 days
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place