Trial Outcomes & Findings for A Study of Mirikizumab (LY3074828) Injection in Healthy Participants (NCT NCT03053622)
NCT ID: NCT03053622
Last Updated: 2024-02-21
Results Overview
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC\[0-∞\]) of Mirikizumab
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
67 participants
Primary outcome timeframe
0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dose
Results posted on
2024-02-21
Participant Flow
Participant milestones
| Measure |
Mirikizumab Reference
250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants.
|
Mirikizumab Test SC 2
250 mg mirikizumab test formulation given as two injections given SC in healthy participants
|
Mirikizumab Test SC 1
250 mg mirikizumab test formulation given as a single injection SC in healthy participants
|
Mirikizumab Test Intravenous (IV)
250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
17
|
16
|
17
|
17
|
|
Overall Study
Received at Least One Dose of Study Drug
|
17
|
16
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
16
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Mirikizumab Reference
250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants.
|
Mirikizumab Test SC 2
250 mg mirikizumab test formulation given as two injections given SC in healthy participants
|
Mirikizumab Test SC 1
250 mg mirikizumab test formulation given as a single injection SC in healthy participants
|
Mirikizumab Test Intravenous (IV)
250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of Mirikizumab (LY3074828) Injection in Healthy Participants
Baseline characteristics by cohort
| Measure |
Mirikizumab Reference
n=17 Participants
250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants.
|
Mirikizumab Test SC 2
n=16 Participants
250 mg mirikizumab test formulation given as two injections given SC in healthy participants
|
Mirikizumab Test SC 1
n=17 Participants
250 mg mirikizumab test formulation given as a single injection SC in healthy participants
|
Mirikizumab Test Intravenous (IV)
n=17 Participants
250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 13.3 • n=39 Participants
|
40.7 years
STANDARD_DEVIATION 18.0 • n=41 Participants
|
52.1 years
STANDARD_DEVIATION 9.6 • n=35 Participants
|
43.6 years
STANDARD_DEVIATION 14.9 • n=31 Participants
|
45.4 years
STANDARD_DEVIATION 14.5 • n=146 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
9 Participants
n=35 Participants
|
8 Participants
n=31 Participants
|
28 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
8 Participants
n=35 Participants
|
9 Participants
n=31 Participants
|
39 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
15 Participants
n=31 Participants
|
65 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=39 Participants
|
13 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
16 Participants
n=31 Participants
|
63 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Region of Enrollment
United Kingdom
|
17 Participants
n=39 Participants
|
16 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
17 Participants
n=31 Participants
|
67 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC\[0-∞\]) of Mirikizumab
Outcome measures
| Measure |
Mirikizumab Reference
n=17 Participants
250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants.
|
Mirikizumab Test SC 2
n=16 Participants
250 mg mirikizumab test formulation given as two injections given SC in healthy participants
|
Mirikizumab Test SC 1
n=17 Participants
250 mg mirikizumab test formulation given as a single injection SC in healthy participants
|
Mirikizumab Test Intravenous (IV)
n=17 Participants
250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From 0 to Infinity (AUC[0-∞]) of Mirikizumab
|
215 Microgram* Day/Milliliter(µg*day/mL)
Geometric Coefficient of Variation 31
|
214 Microgram* Day/Milliliter(µg*day/mL)
Geometric Coefficient of Variation 55
|
293 Microgram* Day/Milliliter(µg*day/mL)
Geometric Coefficient of Variation 36
|
695 Microgram* Day/Milliliter(µg*day/mL)
Geometric Coefficient of Variation 22
|
SECONDARY outcome
Timeframe: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
PK: Maximum Observed Concentration (Cmax) of Mirikizumab
Outcome measures
| Measure |
Mirikizumab Reference
n=17 Participants
250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants.
|
Mirikizumab Test SC 2
n=16 Participants
250 mg mirikizumab test formulation given as two injections given SC in healthy participants
|
Mirikizumab Test SC 1
n=17 Participants
250 mg mirikizumab test formulation given as a single injection SC in healthy participants
|
Mirikizumab Test Intravenous (IV)
n=17 Participants
250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants
|
|---|---|---|---|---|
|
PK: Maximum Observed Concentration (Cmax) of Mirikizumab
|
11.4 Microgram/Milliliter (µg/mL)
Geometric Coefficient of Variation 34
|
11.2 Microgram/Milliliter (µg/mL)
Geometric Coefficient of Variation 51
|
14.9 Microgram/Milliliter (µg/mL)
Geometric Coefficient of Variation 32
|
90.0 Microgram/Milliliter (µg/mL)
Geometric Coefficient of Variation 14
|
SECONDARY outcome
Timeframe: 0,end of infusion,2,6 hours(h); 24 h; 72 h; 168 h; 240 h; 336 h; 504 h; 672 h; 1008 h; 1344 h; 1680 h; 2016 h, post dosePopulation: All participants who received at least one dose of study drug and had evaluable PK data.
PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab
Outcome measures
| Measure |
Mirikizumab Reference
n=17 Participants
250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants.
|
Mirikizumab Test SC 2
n=16 Participants
250 mg mirikizumab test formulation given as two injections given SC in healthy participants
|
Mirikizumab Test SC 1
n=17 Participants
250 mg mirikizumab test formulation given as a single injection SC in healthy participants
|
Mirikizumab Test Intravenous (IV)
n=17 Participants
250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants
|
|---|---|---|---|---|
|
PK: Time of Maximum Observed Drug Concentration (Tmax) of Mirikizumab
|
73.12 Hour (h)
Interval 72.45 to 145.82
|
73.41 Hour (h)
Interval 72.67 to 240.67
|
73.25 Hour (h)
Interval 72.22 to 145.3
|
2.00 Hour (h)
Interval 0.5 to 2.15
|
Adverse Events
Mirikizumab Reference
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Mirikizumab Test SC 2
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Mirikizumab Test SC 1
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Mirikizumab Test Intravenous (IV)
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Mirikizumab Reference
n=17 participants at risk
250 mg mirikizumab reference formulation given as three injections subcutaneous (SC) in healthy participants.
|
Mirikizumab Test SC 2
n=16 participants at risk
250 mg mirikizumab test formulation given as two injections given SC in healthy participants
|
Mirikizumab Test SC 1
n=17 participants at risk
250 mg mirikizumab test formulation given as a single injection SC in healthy participants
|
Mirikizumab Test Intravenous (IV)
n=17 participants at risk
250 mg mirikizumab test formulation given as an infusion into the vein in healthy participants
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Eye disorders
Eye pain
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.8%
2/17 • Number of events 2 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site bruising
|
11.8%
2/17 • Number of events 2 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site mass
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site pain
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site pruritus
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 2 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction
|
100.0%
17/17 • Number of events 47 • Up To 4 Months
All participants who received at least one dose of study drug.
|
93.8%
15/16 • Number of events 33 • Up To 4 Months
All participants who received at least one dose of study drug.
|
100.0%
17/17 • Number of events 18 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Gingivitis
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
29.4%
5/17 • Number of events 5 • Up To 4 Months
All participants who received at least one dose of study drug.
|
12.5%
2/16 • Number of events 2 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
41.2%
7/17 • Number of events 7 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 3 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
11.8%
2/17 • Number of events 2 • Up To 4 Months
All participants who received at least one dose of study drug.
|
12.5%
2/16 • Number of events 2 • Up To 4 Months
All participants who received at least one dose of study drug.
|
11.8%
2/17 • Number of events 2 • Up To 4 Months
All participants who received at least one dose of study drug.
|
23.5%
4/17 • Number of events 7 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Bladder irritation
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
6.2%
1/16 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/16 • Up To 4 Months
All participants who received at least one dose of study drug.
|
0.00%
0/17 • Up To 4 Months
All participants who received at least one dose of study drug.
|
5.9%
1/17 • Number of events 1 • Up To 4 Months
All 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
Restriction type: GT60