Trial Outcomes & Findings for A Study of Two Formulations of LY3074828 in Healthy Participants (NCT NCT03662100)
NCT ID: NCT03662100
Last Updated: 2024-01-25
Results Overview
Pharmacokinetics: Cmax of LY3074828
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
66 participants
Primary outcome timeframe
Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dose
Results posted on
2024-01-25
Participant Flow
Participant milestones
| Measure |
Test 1: 250 mg LY3074828
Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-milligram/milliliter \[mg/mL\]) administered subcutaneously(SC) via an auto-injector (AI) in arm.
|
Test 2: 250 mg LY3074828
Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh.
|
Test 3: 250 mg LY3074828
Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen.
|
Reference 1: 250 mg LY3074828
Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm.The second injection was administered 20 (±2) minutes after the first injection.
|
Reference 2: 250 mg LY3074828
Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh. The second injection was administered 20 (±2) minutes after the first injection.
|
Reference 3: 250 mg LY3074828
Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen.The second injection was administered 20 (±2) minutes after the first injection.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
11
|
11
|
11
|
11
|
11
|
|
Overall Study
Received at Least One Dose of 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 Two Formulations of LY3074828 in Healthy Participants
Baseline characteristics by cohort
| Measure |
Test 1: 250 mg LY3074828
n=11 Participants
Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an auto-injector (AI) in arm.
|
Test 2: 250 mg LY3074828
n=11 Participants
Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh.
|
Test 3: 250 mg LY3074828
n=11 Participants
Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen.
|
Reference 1: 250 mg LY3074828
n=11 Participants
Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm.The second injection was administered 20 (±2) minutes after the first injection.
|
Reference 2: 250 mg LY3074828
n=11 Participants
Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh.The second injection was administered 20 (±2) minutes after the first injection.
|
Reference 3: 250 mg LY3074828
n=11 Participants
Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen.The second injection was administered 20 (±2) minutes after the first injection.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
44.6 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
39.9 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
45.4 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
44.1 years
STANDARD_DEVIATION 14.7 • n=4 Participants
|
42.8 years
STANDARD_DEVIATION 12.3 • n=21 Participants
|
45.0 years
STANDARD_DEVIATION 12.9 • n=8 Participants
|
43.6 years
STANDARD_DEVIATION 12.6 • n=8 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
27 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
38 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
14 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
11 Participants
n=8 Participants
|
48 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
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=8 Participants
|
66 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dosePopulation: All participants who received at least one dose of study drug. Per protocol, PK analysis were performed to compare all PFS participants together versus all AI participants together.
Pharmacokinetics: Cmax of LY3074828
Outcome measures
| Measure |
250 mg LY3074828 AI
n=33 Participants
Test 1: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an auto-injector (AI) in arm.
Test 2: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh.
Test 3: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen.
|
250 mg LY3074828 PFS
n=33 Participants
Reference 1: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm.
Reference 2: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh.
Reference 3: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen.
The second injection was administered 20 (±2) minutes after the first injection.
|
250 mg LY3074828 PFS Second Injection
Reference 1: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm.
Reference 2: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh.
Reference 3: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen.
The second injection was administered 20 (±2) minutes after the first injection.
|
|---|---|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) of LY3074828 by Device
|
22.2 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 40
|
18.7 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 34
|
—
|
PRIMARY outcome
Timeframe: Day 1: 0, 2, 6 hours (hr), Day 2: 24 hr, Day 4, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71, Day 85, Post dosePopulation: All participants who received at least one dose of study drug. Per protocol, PK analysis were performed to compare all PFS participants together versus all AI participants together.
Pharmacokinetics: Area Under the Concentration versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828
Outcome measures
| Measure |
250 mg LY3074828 AI
n=33 Participants
Test 1: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an auto-injector (AI) in arm.
Test 2: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh.
Test 3: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen.
|
250 mg LY3074828 PFS
n=33 Participants
Reference 1: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm.
Reference 2: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh.
Reference 3: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen.
The second injection was administered 20 (±2) minutes after the first injection.
|
250 mg LY3074828 PFS Second Injection
Reference 1: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm.
Reference 2: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh.
Reference 3: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen.
The second injection was administered 20 (±2) minutes after the first injection.
|
|---|---|---|---|
|
Pharmacokinetics: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC(0-∞)) of LY3074828 by Device
|
357 microgram*day per millileter (μg*day/mL)
Geometric Coefficient of Variation 38
|
340 microgram*day per millileter (μg*day/mL)
Geometric Coefficient of Variation 38
|
—
|
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 VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain.
Outcome measures
| Measure |
250 mg LY3074828 AI
n=33 Participants
Test 1: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an auto-injector (AI) in arm.
Test 2: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh.
Test 3: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen.
|
250 mg LY3074828 PFS
n=33 Participants
Reference 1: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm.
Reference 2: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh.
Reference 3: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen.
The second injection was administered 20 (±2) minutes after the first injection.
|
250 mg LY3074828 PFS Second Injection
n=33 Participants
Reference 1: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm.
Reference 2: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh.
Reference 3: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen.
The second injection was administered 20 (±2) minutes after the first injection.
|
|---|---|---|---|
|
Visual Analogue Scale (VAS) Pain Assessment by Device
1 min
|
25.2 millimeter
Standard Deviation 20.0
|
22.6 millimeter
Standard Deviation 18.3
|
18.3 millimeter
Standard Deviation 15.1
|
|
Visual Analogue Scale (VAS) Pain Assessment by Device
5 min (±1.5)
|
12.0 millimeter
Standard Deviation 15.8
|
6.1 millimeter
Standard Deviation 7.0
|
6.0 millimeter
Standard Deviation 6.7
|
|
Visual Analogue Scale (VAS) Pain Assessment by Device
15 min (±2)
|
1.9 millimeter
Standard Deviation 3.1
|
2.4 millimeter
Standard Deviation 2.8
|
2.2 millimeter
Standard Deviation 4.3
|
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 VAS is a single-item participant-rated assessment of injection pain. Score is reported on a continuous scale of 0 to 100. Higher values indicate more pain.
Outcome measures
| Measure |
250 mg LY3074828 AI
n=33 Participants
Test 1: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an auto-injector (AI) in arm.
Test 2: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh.
Test 3: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen.
|
250 mg LY3074828 PFS
n=33 Participants
Reference 1: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm.
Reference 2: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh.
Reference 3: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen.
The second injection was administered 20 (±2) minutes after the first injection.
|
250 mg LY3074828 PFS Second Injection
n=33 Participants
Reference 1: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm.
Reference 2: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh.
Reference 3: 250 mg LY3074828 Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen.
The second injection was administered 20 (±2) minutes after the first injection.
|
|---|---|---|---|
|
Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location
Abdomen: 5 min (±1.5)
|
17.4 millimeter
Standard Deviation 23.3
|
7.5 millimeter
Standard Deviation 8.8
|
5.0 millimeter
Standard Deviation 6.4
|
|
Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location
Arm: 1 min
|
25.9 millimeter
Standard Deviation 17.2
|
19.0 millimeter
Standard Deviation 12.0
|
15.6 millimeter
Standard Deviation 12.3
|
|
Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location
Arm: 5 min (±1.5)
|
5.6 millimeter
Standard Deviation 5.4
|
4.5 millimeter
Standard Deviation 5.5
|
5.0 millimeter
Standard Deviation 6.0
|
|
Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location
Arm: 15 min (±2)
|
2.6 millimeter
Standard Deviation 4.8
|
1.8 millimeter
Standard Deviation 2.4
|
2.0 millimeter
Standard Deviation 2.9
|
|
Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location
Thigh: 1 min
|
26.8 millimeter
Standard Deviation 15.5
|
19.6 millimeter
Standard Deviation 20.9
|
20.5 millimeter
Standard Deviation 19.6
|
|
Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location
Thigh: 5 min (±1.5)
|
13.1 millimeter
Standard Deviation 12.3
|
6.2 millimeter
Standard Deviation 6.6
|
7.9 millimeter
Standard Deviation 7.8
|
|
Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location
Thigh:15 min (±2)
|
0.9 millimeter
Standard Deviation 1.3
|
3.0 millimeter
Standard Deviation 3.6
|
3.5 millimeter
Standard Deviation 6.7
|
|
Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location
Abdomen: 1 min
|
22.9 millimeter
Standard Deviation 27.2
|
29.2 millimeter
Standard Deviation 20.6
|
18.7 millimeter
Standard Deviation 13.4
|
|
Visual Analogue Scale (VAS) Pain Assessment by Device and Injection Site Location
Abdomen: 15 min (±2)
|
2.2 millimeter
Standard Deviation 2.1
|
2.4 millimeter
Standard Deviation 2.4
|
1.2 millimeter
Standard Deviation 1.9
|
Adverse Events
Test 1: 250 mg LY3074828
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Test 2: 250 mg LY3074828
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Test 3: 250 mg LY3074828
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Reference 1: 250 mg LY3074828
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Reference 2: 250 mg LY3074828
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Reference 3: 250 mg LY3074828
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Test 1: 250 mg LY3074828
n=11 participants at risk
Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an auto-injector (AI) in arm.
|
Test 2: 250 mg LY3074828
n=11 participants at risk
Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in thigh.
|
Test 3: 250 mg LY3074828
n=11 participants at risk
Participants received 250 mg LY3074828 solution formulation (1 x 2-mL 125-mg/mL) administered SC via an AI in abdomen.
|
Reference 1: 250 mg LY3074828
n=11 participants at risk
Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in pre-filled syringe (PFS) administered as subcutaneous (SC) injection in arm.The second injection was administered 20 (±2) minutes after the first injection.
|
Reference 2: 250 mg LY3074828
n=11 participants at risk
Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in thigh.The second injection was administered 20 (±2) minutes after the first injection.
|
Reference 3: 250 mg LY3074828
n=11 participants at risk
Participants received 250 mg LY3074828 solution formulation (2 x 1-mL 125-mg/mL) in PFS administered as SC injection in abdomen.The second injection was administered 20 (±2) minutes after the first injection.
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Tachycardia
|
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.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Eye disorders
Refraction disorder
|
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.
|
|
Gastrointestinal disorders
Nausea
|
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.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
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.
|
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.
|
|
General disorders
Injection site bruising
|
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.
|
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.
|
|
Infections and infestations
Nasopharyngitis
|
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.
|
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.
|
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.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
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
Laceration
|
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
Limb injury
|
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.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
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.
|
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
Blood creatine phosphokinase increased
|
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.
|
9.1%
1/11 • Number of events 1 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Investigations
Blood pressure increased
|
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.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
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.
|
|
Nervous system disorders
Headache
|
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.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
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.
|
|
Psychiatric disorders
Anxiety
|
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.
|
0.00%
0/11 • Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
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.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
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.
|
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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
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.
|
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60