Trial Outcomes & Findings for A Study of LY3832479 (LY-CoV016) in Healthy Participants 1 (NCT NCT04611789)
NCT ID: NCT04611789
Last Updated: 2021-12-06
Results Overview
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time 0 to tlast (AUC\[0-tlast\]) of LY3832479.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
18 participants
Primary outcome timeframe
Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose
Results posted on
2021-12-06
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received single subcutaneous dose of Placebo.
|
350 mg LY3832479
Participants received single subcutaneous dose of 350 mg LY3832479.
|
1000 mg LY3832479
Participants received single subcutaneous dose of 1000 mg LY3832479.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
7
|
7
|
|
Overall Study
COMPLETED
|
3
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received single subcutaneous dose of Placebo.
|
350 mg LY3832479
Participants received single subcutaneous dose of 350 mg LY3832479.
|
1000 mg LY3832479
Participants received single subcutaneous dose of 1000 mg LY3832479.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
A Study of LY3832479 (LY-CoV016) in Healthy Participants 1
Baseline characteristics by cohort
| Measure |
Placebo
n=4 Participants
Participants received single subcutaneous dose of Placebo.
|
350 mg LY3832479
n=7 Participants
Participants received single subcutaneous dose of 350 mg LY3832479.
|
1000 mg LY3832479
n=7 Participants
Participants received single subcutaneous dose of 1000 mg LY3832479.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
33.8 Years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
49.0 Years
STANDARD_DEVIATION 12.4 • n=7 Participants
|
42.7 Years
STANDARD_DEVIATION 13.3 • n=5 Participants
|
43.2 Years
STANDARD_DEVIATION 13.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 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
|
|
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
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 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
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdosePopulation: All randomized participants who received study drug and had evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time 0 to tlast (AUC\[0-tlast\]) of LY3832479.
Outcome measures
| Measure |
350 mg LY3832479
n=7 Participants
Participants received single subcutaneous dose of 350 mg LY3832479.
|
1000 mg LY3832479
n=7 Participants
Participants received single subcutaneous dose of 1000 mg LY3832479.
|
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Tlast (AUC[0-tlast]) of LY3832479
|
1560 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 80
|
4530 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 31
|
PRIMARY outcome
Timeframe: Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdosePopulation: All randomized participants who received study drug and had evaluable PK data.
PK: Maximum Serum Concentration (Cmax) of LY3832479.
Outcome measures
| Measure |
350 mg LY3832479
n=7 Participants
Participants received single subcutaneous dose of 350 mg LY3832479.
|
1000 mg LY3832479
n=7 Participants
Participants received single subcutaneous dose of 1000 mg LY3832479.
|
|---|---|---|
|
PK: Maximum Serum Concentration (Cmax) of LY3832479
|
39.1 μg/mL
Geometric Coefficient of Variation 39
|
91.9 μg/mL
Geometric Coefficient of Variation 35
|
Adverse Events
Placebo SC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
350 mg LY3832479 SC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
1000 mg LY3832479 SC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo SC
n=4 participants at risk
Participants received single subcutaneous dose of Placebo.
|
350 mg LY3832479 SC
n=7 participants at risk
Participants received single subcutaneous dose of 350 mg LY3832479.
|
1000 mg LY3832479 SC
n=7 participants at risk
Participants received single subcutaneous dose of 1000 mg LY3832479.
|
|---|---|---|---|
|
General disorders
Injection site reaction
|
0.00%
0/4 • Baseline, upto 3 Months
All randomized participants.
|
0.00%
0/7 • Baseline, upto 3 Months
All randomized participants.
|
14.3%
1/7 • Number of events 4 • Baseline, upto 3 Months
All randomized participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60