Trial Outcomes & Findings for A Study of Injections of LY3074828 in Healthy Participants (NCT NCT03886948)
NCT ID: NCT03886948
Last Updated: 2024-02-20
Results Overview
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
66 participants
Primary outcome timeframe
Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85
Results posted on
2024-02-20
Participant Flow
Participant milestones
| Measure |
Test 1: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation subcutaneously (SC) via 1-mL Autoinjector (AI) administered in the arm.
|
Test 2: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the thigh.
|
Test 3: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen.
|
Reference 1: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL pre-filled syringe (PFS) administered in the arm.
|
Reference 2: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh.
|
Reference 3: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
11
|
11
|
11
|
11
|
|
Overall Study
Received at Least One Dose of Study Drug
|
11
|
11
|
11
|
11
|
11
|
11
|
|
Overall Study
COMPLETED
|
11
|
11
|
11
|
11
|
11
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Injections of LY3074828 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Test 1: 125 mg LY3074828
n=11 Participants
Participants received 125 mg LY3074828 solution formulation subcutaneously (SC) via 1-mL Autoinjector (AI) administered in the arm.
|
Test 2: 125 mg LY3074828
n=11 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the thigh.
|
Test 3: 125 mg LY3074828
n=11 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen.
|
Reference 1: 125 mg LY3074828
n=11 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL pre-filled syringe (PFS) administered in the arm.
|
Reference 2: 125 mg LY3074828
n=11 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh.
|
Reference 3: 125 mg LY3074828
n=11 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41.3 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
44.8 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
37.3 years
STANDARD_DEVIATION 15.2 • n=4 Participants
|
41.3 years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
43.5 years
STANDARD_DEVIATION 10.8 • n=10 Participants
|
40.7 years
STANDARD_DEVIATION 12.3 • n=115 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
36 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
30 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
21 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
45 Participants
n=115 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=10 Participants
|
0 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
48 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
66 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85Population: All participants who received at least one dose of study drug and had evaluable PK data. Per protocol, PK analysis were performed to evaluate solution formulation using a 1-mL PFS and a 1-mL AI.
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828
Outcome measures
| Measure |
125 mg LY3074828 AI
n=33 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the arm, thigh or abdomen.
|
125 mg LY3074828 PFS
n=33 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the arm, thigh or abdomen.
|
Test 3: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen.
|
Reference 1: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL pre-filled syringe (PFS) administered in the arm.
|
Reference 2: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh.
|
Reference 3: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen.
|
|---|---|---|---|---|---|---|
|
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3074828
|
9.19 microgram/milliliter (ug/mL)
Geometric Coefficient of Variation 44
|
8.19 microgram/milliliter (ug/mL)
Geometric Coefficient of Variation 56
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85Population: All participants who received at least one dose of study drug and had evaluable PK data. Per protocol, PK analysis were performed to evaluate solution formulation using a 1-mL PFS and a 1-mL AI.
PK: Area Under the Concentration Versus Time Curve from Time Zero to Time t (AUC(0-tlast) of LY3074828, where t is the Last Sample with a Measurable Concentration
Outcome measures
| Measure |
125 mg LY3074828 AI
n=33 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the arm, thigh or abdomen.
|
125 mg LY3074828 PFS
n=33 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the arm, thigh or abdomen.
|
Test 3: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen.
|
Reference 1: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL pre-filled syringe (PFS) administered in the arm.
|
Reference 2: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh.
|
Reference 3: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen.
|
|---|---|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Time t (AUC(0-tlast) of LY3074828, Where t is the Last Sample With a Measurable Concentration
|
146 microgram*day/milliliter (ug*day/mL)
Geometric Coefficient of Variation 39
|
130 microgram*day/milliliter (ug*day/mL)
Geometric Coefficient of Variation 51
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: 0, 2, 6 hours, Day 2: 24 hours, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85Population: All participants who received at least one dose of study drug and had evaluable PK data. Per protocol, PK analysis were performed to evaluate formulation using a 1-mL PFS and a 1-mL AI.
PK: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC\[0-∞\]) of LY3074828
Outcome measures
| Measure |
125 mg LY3074828 AI
n=33 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the arm, thigh or abdomen.
|
125 mg LY3074828 PFS
n=33 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the arm, thigh or abdomen.
|
Test 3: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen.
|
Reference 1: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL pre-filled syringe (PFS) administered in the arm.
|
Reference 2: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh.
|
Reference 3: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen.
|
|---|---|---|---|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3074828
|
149 ug*day/mL
Geometric Coefficient of Variation 38
|
133 ug*day/mL
Geometric Coefficient of Variation 50
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: 1, 5 (±1.5) and 15 (±2) minutesPopulation: All participants who received at least one dose of study drug.
The pain VAS is a participant-administered single-item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. 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 (severe pain).
Outcome measures
| Measure |
125 mg LY3074828 AI
n=33 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the arm, thigh or abdomen.
|
125 mg LY3074828 PFS
n=33 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the arm, thigh or abdomen.
|
Test 3: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen.
|
Reference 1: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL pre-filled syringe (PFS) administered in the arm.
|
Reference 2: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh.
|
Reference 3: 125 mg LY3074828
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen.
|
|---|---|---|---|---|---|---|
|
Visual Analog Scale (VAS) Pain Score by Device
1 Minute
|
27.2 millimeter (mm)
Standard Deviation 25.0
|
22.9 millimeter (mm)
Standard Deviation 21.5
|
—
|
—
|
—
|
—
|
|
Visual Analog Scale (VAS) Pain Score by Device
5 Minutes (±1.5)
|
8.3 millimeter (mm)
Standard Deviation 14.3
|
10.9 millimeter (mm)
Standard Deviation 15.5
|
—
|
—
|
—
|
—
|
|
Visual Analog Scale (VAS) Pain Score by Device
15 Minute (±2)
|
2.3 millimeter (mm)
Standard Deviation 5.8
|
2.8 millimeter (mm)
Standard Deviation 6.3
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 1: 1, 5 (±1.5) and 15 (±2) minutesPopulation: All participants who received at least one dose of study drug.
The pain VAS is a participant-administered single-item scale designed to measure pain using a 0-100 millimeter (mm) horizontal VAS. 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 (severe pain).
Outcome measures
| Measure |
125 mg LY3074828 AI
n=11 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the arm, thigh or abdomen.
|
125 mg LY3074828 PFS
n=11 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the arm, thigh or abdomen.
|
Test 3: 125 mg LY3074828
n=11 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen.
|
Reference 1: 125 mg LY3074828
n=11 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL pre-filled syringe (PFS) administered in the arm.
|
Reference 2: 125 mg LY3074828
n=11 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh.
|
Reference 3: 125 mg LY3074828
n=11 Participants
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen.
|
|---|---|---|---|---|---|---|
|
Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location
1 Minute
|
30.1 millimeter (mm)
Standard Deviation 24.9
|
27.4 millimeter (mm)
Standard Deviation 30.5
|
24.1 millimeter (mm)
Standard Deviation 20.9
|
26.7 millimeter (mm)
Standard Deviation 23.5
|
22.5 millimeter (mm)
Standard Deviation 25.6
|
19.5 millimeter (mm)
Standard Deviation 15.5
|
|
Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location
5 Minutes (±1.5)
|
6.5 millimeter (mm)
Standard Deviation 9.8
|
12.2 millimeter (mm)
Standard Deviation 22.0
|
6.4 millimeter (mm)
Standard Deviation 7.1
|
11.8 millimeter (mm)
Standard Deviation 20.1
|
8.9 millimeter (mm)
Standard Deviation 13.7
|
11.9 millimeter (mm)
Standard Deviation 13.2
|
|
Visual Analog Scale (VAS) Pain Score by Device and Injection Site Location
15 Minutes (±2)
|
1.8 millimeter (mm)
Standard Deviation 2.9
|
3.8 millimeter (mm)
Standard Deviation 9.5
|
1.4 millimeter (mm)
Standard Deviation 2.5
|
3.6 millimeter (mm)
Standard Deviation 10.1
|
1.7 millimeter (mm)
Standard Deviation 2.0
|
3.1 millimeter (mm)
Standard Deviation 4.4
|
Adverse Events
Test 1: 125 mg LY3074828
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Test 2: 125 mg LY3074828
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Test 3: 125 mg LY3074828
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Reference 1: 125 mg LY3074828
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Reference 2: 125 mg LY3074828
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Reference 3: 125 mg LY3074828
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test 1: 125 mg LY3074828
n=11 participants at risk
Participants received 125 mg LY3074828 solution formulation subcutaneously (SC) via 1-mL Autoinjector (AI) administered in the arm.
|
Test 2: 125 mg LY3074828
n=11 participants at risk
Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the thigh.
|
Test 3: 125 mg LY3074828
n=11 participants at risk
Participants received 125 mg LY3074828 solution formulation SC via 1-mL AI administered in the abdomen.
|
Reference 1: 125 mg LY3074828
n=11 participants at risk
Participants received 125 mg LY3074828 solution formulation SC via 1-mL pre-filled syringe (PFS) administered in the arm.
|
Reference 2: 125 mg LY3074828
n=11 participants at risk
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the thigh.
|
Reference 3: 125 mg LY3074828
n=11 participants at risk
Participants received 125 mg LY3074828 solution formulation SC via 1-mL PFS administered in the abdomen.
|
|---|---|---|---|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
18.2%
2/11 • Number of events 2 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction
|
9.1%
1/11 • Number of events 1 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
9.1%
1/11 • Number of events 1 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Investigations
Laboratory test abnormal
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 3 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up To 85 Days
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up To 85 Days
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up To 85 Days
All participants who received at least one dose of study drug.
|
27.3%
3/11 • Number of events 4 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
9.1%
1/11 • Number of events 1 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
0.00%
0/11 • Up To 85 Days
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