Trial Outcomes & Findings for A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis (NCT NCT03418493)
NCT ID: NCT03418493
Last Updated: 2023-09-21
Results Overview
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is reported in the Reported Adverse Events module. An SAE is any adverse event from this study that results in 1 of the following: 1. Death 2. Initial or prolonged inpatient hospitalization 3. A life-threatening experience (that is, immediate risk of dying) 4. Persistent or significant disability/incapacity 5. Congenital anomaly/birth defect 6. Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
63 participants
Primary outcome timeframe
Pre-dose up to 1 year after administration of study drug
Results posted on
2023-09-21
Participant Flow
Study consists of three parts: * Part A (Single-Ascending Dose (SAD) in healthy participants) * Part B (Multiple-dose in healthy participants) and * Part C (Single dose in psoriasis participants)
Participant milestones
| Measure |
Placebo - Part A
Participants received single IV doses of Placebo.
|
3 mg LY3316531 IV - Part A
Participants received single doses of 3 milligrams (mg) LY3316531 administered Intravenously (IV).
|
15 mg LY3316531 IV - Part A
Participants received single doses of 15 mg LY3316531 administered IV.
|
75 mg LY3316531 IV - Part A
Participants received single doses of 75 mg LY3316531 administered IV.
|
300 mg LY3316531 IV - Part A
Participants received single doses of 300 mg LY3316531 administered IV.
|
300 mg LY3316531 SC- Part A
Participants received single doses of 300 mg LY3316531 administered Subcutaneously (SC).
|
900 mg LY3316531 IV - Part A
Participants received single doses of 900 mg LY3316531 administered IV.
|
2000 mg LY3316531 IV - Part A
Participants received single doses of 2000 mg LY3316531 administered IV.
|
Placebo - Part B
Participants received 3 doses of Placebo administered IV (1 dose every 4 weeks).
|
2000 mg LY3316531 IV - Part B
Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).
|
300 mg LY3316531 IV - Part C
Participants with psoriasis received single doses of 300 mg LY3316531 administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
3
|
3
|
6
|
6
|
6
|
6
|
6
|
2
|
6
|
8
|
|
Overall Study
COMPLETED
|
10
|
3
|
3
|
6
|
6
|
6
|
6
|
6
|
2
|
5
|
8
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Placebo - Part A
Participants received single IV doses of Placebo.
|
3 mg LY3316531 IV - Part A
Participants received single doses of 3 milligrams (mg) LY3316531 administered Intravenously (IV).
|
15 mg LY3316531 IV - Part A
Participants received single doses of 15 mg LY3316531 administered IV.
|
75 mg LY3316531 IV - Part A
Participants received single doses of 75 mg LY3316531 administered IV.
|
300 mg LY3316531 IV - Part A
Participants received single doses of 300 mg LY3316531 administered IV.
|
300 mg LY3316531 SC- Part A
Participants received single doses of 300 mg LY3316531 administered Subcutaneously (SC).
|
900 mg LY3316531 IV - Part A
Participants received single doses of 900 mg LY3316531 administered IV.
|
2000 mg LY3316531 IV - Part A
Participants received single doses of 2000 mg LY3316531 administered IV.
|
Placebo - Part B
Participants received 3 doses of Placebo administered IV (1 dose every 4 weeks).
|
2000 mg LY3316531 IV - Part B
Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).
|
300 mg LY3316531 IV - Part C
Participants with psoriasis received single doses of 300 mg LY3316531 administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis
Baseline characteristics by cohort
| Measure |
Placebo - Part A
n=11 Participants
Participants received single IV doses of Placebo.
|
3 mg LY3316531 IV - Part A
n=3 Participants
Participants received single doses of 3 milligrams (mg) LY3316531 administered Intravenously (IV).
|
15 mg LY3316531 IV - Part A
n=3 Participants
Participants received single doses of 15 mg LY3316531 administered IV.
|
75 mg LY3316531 IV - Part A
n=6 Participants
Participants received single doses of 75 mg LY3316531 administered IV.
|
300 mg LY3316531 IV - Part A
n=6 Participants
Participants received single doses of 300 mg LY3316531 administered IV.
|
300 mg LY3316531 SC- Part A
n=6 Participants
Participants received single doses of 300 mg LY3316531 administered Subcutaneously (SC).
|
900 mg LY3316531 IV - Part A
n=6 Participants
Participants received single doses of 900 mg LY3316531 administered IV.
|
2000 mg LY3316531 IV - Part A
n=6 Participants
Participants received single doses of 2000 mg LY3316531 administered IV.
|
Placebo - Part B
n=2 Participants
Participants received 3 doses of Placebo administered IV (1 dose every 4 weeks).
|
2000 mg LY3316531 IV - Part B
n=6 Participants
Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).
|
300 mg LY3316531 IV - Part C
n=8 Participants
Participants with psoriasis received single doses of 300 mg LY3316531 administered IV.
|
Total
n=63 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
63 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
46 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
46 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
3 Participants
n=42 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
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
4 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
34 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
4 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
2 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
63 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Pre-dose up to 1 year after administration of study drugPopulation: All randomized participants who received study drug.
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is reported in the Reported Adverse Events module. An SAE is any adverse event from this study that results in 1 of the following: 1. Death 2. Initial or prolonged inpatient hospitalization 3. A life-threatening experience (that is, immediate risk of dying) 4. Persistent or significant disability/incapacity 5. Congenital anomaly/birth defect 6. Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above.
Outcome measures
| Measure |
Placebo - Part A
n=11 Participants
Participants received single IV doses of Placebo.
|
3 mg LY3316531 IV - Part A
n=3 Participants
Participants received single doses of 3 milligrams (mg) LY3316531 administered Intravenously (IV).
|
15 mg LY3316531 IV - Part A
n=3 Participants
Participants received single doses of 15 mg LY3316531 administered IV.
|
75 mg LY3316531 IV - Part A
n=6 Participants
Participants received single doses of 75 mg LY3316531 administered IV.
|
300 mg LY3316531 IV - Part A
n=6 Participants
Participants received single doses of 300 mg LY3316531 administered IV.
|
300 mg LY3316531 SC- Part A
n=6 Participants
Participants received single doses of 300 mg LY3316531 administered Subcutaneously (SC).
|
900 mg LY3316531 IV - Part A
n=6 Participants
Participants received single doses of 900 mg LY3316531 administered IV.
|
2000 mg LY3316531 IV - Part A
n=6 Participants
Participants received single doses of 2000 mg LY3316531 administered IV.
|
Placebo - Part B
n=2 Participants
Participants received 3 doses of Placebo administered IV (1 dose every 4 weeks).
|
2000 mg LY3316531 IV - Part B
n=6 Participants
Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).
|
300 mg LY3316531 IV - Part C
n=8 Participants
Participants with psoriasis received single doses of 300 mg LY3316531 administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dosePopulation: All randomized participants in Part A who received study drug and had evaluable PK data.
PK: Cmax of LY3316531. Under time frame, hours was abbreviated as "hrs."
Outcome measures
| Measure |
Placebo - Part A
n=3 Participants
Participants received single IV doses of Placebo.
|
3 mg LY3316531 IV - Part A
n=3 Participants
Participants received single doses of 3 milligrams (mg) LY3316531 administered Intravenously (IV).
|
15 mg LY3316531 IV - Part A
n=6 Participants
Participants received single doses of 15 mg LY3316531 administered IV.
|
75 mg LY3316531 IV - Part A
n=6 Participants
Participants received single doses of 75 mg LY3316531 administered IV.
|
300 mg LY3316531 IV - Part A
n=6 Participants
Participants received single doses of 300 mg LY3316531 administered IV.
|
300 mg LY3316531 SC- Part A
n=6 Participants
Participants received single doses of 300 mg LY3316531 administered Subcutaneously (SC).
|
900 mg LY3316531 IV - Part A
n=6 Participants
Participants received single doses of 900 mg LY3316531 administered IV.
|
2000 mg LY3316531 IV - Part A
Participants received single doses of 2000 mg LY3316531 administered IV.
|
Placebo - Part B
Participants received 3 doses of Placebo administered IV (1 dose every 4 weeks).
|
2000 mg LY3316531 IV - Part B
Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).
|
300 mg LY3316531 IV - Part C
Participants with psoriasis received single doses of 300 mg LY3316531 administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
|
1.27 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 18
|
9.94 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 26
|
32.7 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 22
|
115 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 11
|
27.2 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 30
|
453 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 14
|
808 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 15
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85Population: All randomized participants in Part B who received study drug on Day 57 and had evaluable PK data.
PK: Cmax of LY3316531 following the Day 57 dose.
Outcome measures
| Measure |
Placebo - Part A
n=5 Participants
Participants received single IV doses of Placebo.
|
3 mg LY3316531 IV - Part A
Participants received single doses of 3 milligrams (mg) LY3316531 administered Intravenously (IV).
|
15 mg LY3316531 IV - Part A
Participants received single doses of 15 mg LY3316531 administered IV.
|
75 mg LY3316531 IV - Part A
Participants received single doses of 75 mg LY3316531 administered IV.
|
300 mg LY3316531 IV - Part A
Participants received single doses of 300 mg LY3316531 administered IV.
|
300 mg LY3316531 SC- Part A
Participants received single doses of 300 mg LY3316531 administered Subcutaneously (SC).
|
900 mg LY3316531 IV - Part A
Participants received single doses of 900 mg LY3316531 administered IV.
|
2000 mg LY3316531 IV - Part A
Participants received single doses of 2000 mg LY3316531 administered IV.
|
Placebo - Part B
Participants received 3 doses of Placebo administered IV (1 dose every 4 weeks).
|
2000 mg LY3316531 IV - Part B
Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).
|
300 mg LY3316531 IV - Part C
Participants with psoriasis received single doses of 300 mg LY3316531 administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
|
876 μg/mL
Geometric Coefficient of Variation 14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dosePopulation: All randomized participants in Part C who received study drug and had evaluable PK data.
PK: Cmax of LY3316531.
Outcome measures
| Measure |
Placebo - Part A
n=8 Participants
Participants received single IV doses of Placebo.
|
3 mg LY3316531 IV - Part A
Participants received single doses of 3 milligrams (mg) LY3316531 administered Intravenously (IV).
|
15 mg LY3316531 IV - Part A
Participants received single doses of 15 mg LY3316531 administered IV.
|
75 mg LY3316531 IV - Part A
Participants received single doses of 75 mg LY3316531 administered IV.
|
300 mg LY3316531 IV - Part A
Participants received single doses of 300 mg LY3316531 administered IV.
|
300 mg LY3316531 SC- Part A
Participants received single doses of 300 mg LY3316531 administered Subcutaneously (SC).
|
900 mg LY3316531 IV - Part A
Participants received single doses of 900 mg LY3316531 administered IV.
|
2000 mg LY3316531 IV - Part A
Participants received single doses of 2000 mg LY3316531 administered IV.
|
Placebo - Part B
Participants received 3 doses of Placebo administered IV (1 dose every 4 weeks).
|
2000 mg LY3316531 IV - Part B
Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).
|
300 mg LY3316531 IV - Part C
Participants with psoriasis received single doses of 300 mg LY3316531 administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531
|
124 μg/mL
Geometric Coefficient of Variation 19
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dosePopulation: All randomized participants in Part A who received study drug and had evaluable PK data.
Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).
Outcome measures
| Measure |
Placebo - Part A
n=3 Participants
Participants received single IV doses of Placebo.
|
3 mg LY3316531 IV - Part A
n=3 Participants
Participants received single doses of 3 milligrams (mg) LY3316531 administered Intravenously (IV).
|
15 mg LY3316531 IV - Part A
n=6 Participants
Participants received single doses of 15 mg LY3316531 administered IV.
|
75 mg LY3316531 IV - Part A
n=6 Participants
Participants received single doses of 75 mg LY3316531 administered IV.
|
300 mg LY3316531 IV - Part A
n=6 Participants
Participants received single doses of 300 mg LY3316531 administered IV.
|
300 mg LY3316531 SC- Part A
n=6 Participants
Participants received single doses of 300 mg LY3316531 administered Subcutaneously (SC).
|
900 mg LY3316531 IV - Part A
n=6 Participants
Participants received single doses of 900 mg LY3316531 administered IV.
|
2000 mg LY3316531 IV - Part A
Participants received single doses of 2000 mg LY3316531 administered IV.
|
Placebo - Part B
Participants received 3 doses of Placebo administered IV (1 dose every 4 weeks).
|
2000 mg LY3316531 IV - Part B
Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).
|
300 mg LY3316531 IV - Part C
Participants with psoriasis received single doses of 300 mg LY3316531 administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)
|
401 micrograms*hours per milliliter(μg*h/mL)
Geometric Coefficient of Variation 7
|
3050 micrograms*hours per milliliter(μg*h/mL)
Geometric Coefficient of Variation 23
|
12,700 micrograms*hours per milliliter(μg*h/mL)
Geometric Coefficient of Variation 19
|
46,900 micrograms*hours per milliliter(μg*h/mL)
Geometric Coefficient of Variation 10
|
25,800 micrograms*hours per milliliter(μg*h/mL)
Geometric Coefficient of Variation 27
|
181,000 micrograms*hours per milliliter(μg*h/mL)
Geometric Coefficient of Variation 25
|
319,000 micrograms*hours per milliliter(μg*h/mL)
Geometric Coefficient of Variation 31
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85Population: All randomized participants in Part B who received study drug on Day 57 and had evaluable PK data.
AUC of LY3316531 over the dosing interval (tau = 672 h = 28 days) following the Day 57 dose.
Outcome measures
| Measure |
Placebo - Part A
n=5 Participants
Participants received single IV doses of Placebo.
|
3 mg LY3316531 IV - Part A
Participants received single doses of 3 milligrams (mg) LY3316531 administered Intravenously (IV).
|
15 mg LY3316531 IV - Part A
Participants received single doses of 15 mg LY3316531 administered IV.
|
75 mg LY3316531 IV - Part A
Participants received single doses of 75 mg LY3316531 administered IV.
|
300 mg LY3316531 IV - Part A
Participants received single doses of 300 mg LY3316531 administered IV.
|
300 mg LY3316531 SC- Part A
Participants received single doses of 300 mg LY3316531 administered Subcutaneously (SC).
|
900 mg LY3316531 IV - Part A
Participants received single doses of 900 mg LY3316531 administered IV.
|
2000 mg LY3316531 IV - Part A
Participants received single doses of 2000 mg LY3316531 administered IV.
|
Placebo - Part B
Participants received 3 doses of Placebo administered IV (1 dose every 4 weeks).
|
2000 mg LY3316531 IV - Part B
Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).
|
300 mg LY3316531 IV - Part C
Participants with psoriasis received single doses of 300 mg LY3316531 administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 Over the Dosing Interval (Tau) - AUCtau
|
258,000 μg*h/mL
Geometric Coefficient of Variation 2
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dosePopulation: All randomized participants in Part C who received study drug and had evaluable PK data.
Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).
Outcome measures
| Measure |
Placebo - Part A
n=8 Participants
Participants received single IV doses of Placebo.
|
3 mg LY3316531 IV - Part A
Participants received single doses of 3 milligrams (mg) LY3316531 administered Intravenously (IV).
|
15 mg LY3316531 IV - Part A
Participants received single doses of 15 mg LY3316531 administered IV.
|
75 mg LY3316531 IV - Part A
Participants received single doses of 75 mg LY3316531 administered IV.
|
300 mg LY3316531 IV - Part A
Participants received single doses of 300 mg LY3316531 administered IV.
|
300 mg LY3316531 SC- Part A
Participants received single doses of 300 mg LY3316531 administered Subcutaneously (SC).
|
900 mg LY3316531 IV - Part A
Participants received single doses of 900 mg LY3316531 administered IV.
|
2000 mg LY3316531 IV - Part A
Participants received single doses of 2000 mg LY3316531 administered IV.
|
Placebo - Part B
Participants received 3 doses of Placebo administered IV (1 dose every 4 weeks).
|
2000 mg LY3316531 IV - Part B
Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).
|
300 mg LY3316531 IV - Part C
Participants with psoriasis received single doses of 300 mg LY3316531 administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Part C: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)
|
39,500 μg*h/mL
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Placebo - Part A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
3 mg LY3316531 IV - Part A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
15 mg LY3316531 IV - Part A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
75 mg LY3316531 IV - Part A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
300 mg LY3316531 IV - Part A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
300 mg LY3316531 SC- Part A
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
900 mg LY3316531 IV - Part A
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2000 mg LY3316531 IV - Part A
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo - Part B
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
2000 mg LY3316531 IV - Part B
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
300 mg LY3316531 IV - Part C
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo - Part A
n=11 participants at risk
Participants received single IV doses of Placebo.
|
3 mg LY3316531 IV - Part A
n=3 participants at risk
Participants received single doses of 3 milligrams (mg) LY3316531 administered Intravenously (IV).
|
15 mg LY3316531 IV - Part A
n=3 participants at risk
Participants received single doses of 15 mg LY3316531 administered IV.
|
75 mg LY3316531 IV - Part A
n=6 participants at risk
Participants received single doses of 75 mg LY3316531 administered IV.
|
300 mg LY3316531 IV - Part A
n=6 participants at risk
Participants received single doses of 300 mg LY3316531 administered IV.
|
300 mg LY3316531 SC- Part A
n=6 participants at risk
Participants received single doses of 300 mg LY3316531 administered Subcutaneously (SC).
|
900 mg LY3316531 IV - Part A
n=6 participants at risk
Participants received single doses of 900 mg LY3316531 administered IV.
|
2000 mg LY3316531 IV - Part A
n=6 participants at risk
Participants received single doses of 2000 mg LY3316531 administered IV.
|
Placebo - Part B
n=2 participants at risk
Participants received 3 doses of Placebo administered IV (1 dose every 4 weeks).
|
2000 mg LY3316531 IV - Part B
n=6 participants at risk
Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).
|
300 mg LY3316531 IV - Part C
n=8 participants at risk
Participants with psoriasis received single doses of 300 mg LY3316531 administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Abscess limb
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
Other adverse events
| Measure |
Placebo - Part A
n=11 participants at risk
Participants received single IV doses of Placebo.
|
3 mg LY3316531 IV - Part A
n=3 participants at risk
Participants received single doses of 3 milligrams (mg) LY3316531 administered Intravenously (IV).
|
15 mg LY3316531 IV - Part A
n=3 participants at risk
Participants received single doses of 15 mg LY3316531 administered IV.
|
75 mg LY3316531 IV - Part A
n=6 participants at risk
Participants received single doses of 75 mg LY3316531 administered IV.
|
300 mg LY3316531 IV - Part A
n=6 participants at risk
Participants received single doses of 300 mg LY3316531 administered IV.
|
300 mg LY3316531 SC- Part A
n=6 participants at risk
Participants received single doses of 300 mg LY3316531 administered Subcutaneously (SC).
|
900 mg LY3316531 IV - Part A
n=6 participants at risk
Participants received single doses of 900 mg LY3316531 administered IV.
|
2000 mg LY3316531 IV - Part A
n=6 participants at risk
Participants received single doses of 2000 mg LY3316531 administered IV.
|
Placebo - Part B
n=2 participants at risk
Participants received 3 doses of Placebo administered IV (1 dose every 4 weeks).
|
2000 mg LY3316531 IV - Part B
n=6 participants at risk
Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).
|
300 mg LY3316531 IV - Part C
n=8 participants at risk
Participants with psoriasis received single doses of 300 mg LY3316531 administered IV.
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
50.0%
1/2 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
General disorders
Catheter site extravasation
|
9.1%
1/11 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
General disorders
Chest pain
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
General disorders
Infusion site bruising
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
General disorders
Injection site bruising
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
General disorders
Injection site erythema
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
33.3%
2/6 • Number of events 4 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
General disorders
Injection site pruritus
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Immune system disorders
Allergy to arthropod sting
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
12.5%
1/8 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
12.5%
1/8 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
33.3%
1/3 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
50.0%
1/2 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
12.5%
1/8 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
33.3%
1/3 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Maternal exposure before pregnancy
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
12.5%
1/8 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
12.5%
1/8 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
12.5%
1/8 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
|
Investigations
Pregnancy test positive
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
12.5%
1/8 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.1%
1/11 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
12.5%
1/8 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
33.3%
1/3 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • Number of events 2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
12.5%
1/8 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
12.5%
1/8 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/11 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/3 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
16.7%
1/6 • Number of events 1 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/2 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/6 • Up To 1 Year
All randomized participants who received study drug.
|
0.00%
0/8 • Up To 1 Year
All randomized participants who received study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60