Trial Outcomes & Findings for A Study of LY3832479 (LY-CoV016) in Healthy Participants (NCT NCT04441931)
NCT ID: NCT04441931
Last Updated: 2021-12-06
Results Overview
The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
26 participants
Primary outcome timeframe
Baseline through Follow-up (Week 12)
Results posted on
2021-12-06
Participant Flow
Participant milestones
| Measure |
Pooled Placebo
Participants received single Intravenous (IV) dose of Placebo.
|
700 mg LY3832479 IV
Participants received single IV dose of 700 mg LY3832479.
|
2800 mg LY3832479 IV
Participants received single IV dose of 2800 mg LY3832479.
|
7000 mg LY3832479 IV
Participants received single IV dose of 7000 mg LY3832479.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
7
|
7
|
6
|
|
Overall Study
Received at Least One Dose of Study Drug
|
6
|
7
|
7
|
6
|
|
Overall Study
COMPLETED
|
6
|
7
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY3832479 (LY-CoV016) in Healthy Participants
Baseline characteristics by cohort
| Measure |
Pooled Placebo
n=6 Participants
Participants received single Intravenous (IV) dose of Placebo.
|
700 mg LY3832479 IV
n=7 Participants
Participants received single IV dose of 700 mg LY3832479.
|
2800 mg LY3832479 IV
n=7 Participants
Participants received single IV dose of 2800 mg LY3832479.
|
7000 mg LY3832479 IV
n=6 Participants
Participants received single IV dose of 7000 mg LY3832479.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
42.8 Years
STANDARD_DEVIATION 10.8 • n=93 Participants
|
41.0 Years
STANDARD_DEVIATION 7.4 • n=4 Participants
|
41.4 Years
STANDARD_DEVIATION 11.2 • n=27 Participants
|
45.7 Years
STANDARD_DEVIATION 8.9 • n=483 Participants
|
42.6 Years
STANDARD_DEVIATION 9.3 • n=36 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
3 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
11 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
15 Participants
n=36 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
7 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: Baseline through Follow-up (Week 12)Population: All randomized participants who received at least one dose of study drug.
The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
Outcome measures
| Measure |
Pooled Placebo
n=6 Participants
Participants received single Intravenous (IV) dose of Placebo.
|
700 mg LY3832479 IV
n=7 Participants
Participants received single IV dose of 700 mg LY3832479.
|
2800 mg LY3832479 IV
n=7 Participants
Participants received single IV dose of 2800 mg LY3832479.
|
7000 mg LY3832479 IV
n=6 Participants
Participants received single IV dose of 7000 mg LY3832479.
|
|---|---|---|---|---|
|
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to infinity (AUC\[0-∞\]) of LY3832479.
Outcome measures
| Measure |
Pooled Placebo
n=7 Participants
Participants received single Intravenous (IV) dose of Placebo.
|
700 mg LY3832479 IV
n=7 Participants
Participants received single IV dose of 700 mg LY3832479.
|
2800 mg LY3832479 IV
n=6 Participants
Participants received single IV dose of 2800 mg LY3832479.
|
7000 mg LY3832479 IV
Participants received single IV dose of 7000 mg LY3832479.
|
|---|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479
|
4920 micrograms*day per milliliter(ug*day/mL)
Geometric Coefficient of Variation 23
|
22700 micrograms*day per milliliter(ug*day/mL)
Geometric Coefficient of Variation 22
|
50800 micrograms*day per milliliter(ug*day/mL)
Geometric Coefficient of Variation 33
|
—
|
SECONDARY outcome
Timeframe: Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85Population: All randomized participants who received at least one dose of study drug and had evaluable PK data.
PK: Maximum Serum Concentration (Cmax) of LY3832479.
Outcome measures
| Measure |
Pooled Placebo
n=7 Participants
Participants received single Intravenous (IV) dose of Placebo.
|
700 mg LY3832479 IV
n=7 Participants
Participants received single IV dose of 700 mg LY3832479.
|
2800 mg LY3832479 IV
n=6 Participants
Participants received single IV dose of 2800 mg LY3832479.
|
7000 mg LY3832479 IV
Participants received single IV dose of 7000 mg LY3832479.
|
|---|---|---|---|---|
|
PK: Maximum Serum Concentration (Cmax) of LY3832479
|
244 ug/mL
Geometric Coefficient of Variation 24
|
1130 ug/mL
Geometric Coefficient of Variation 14
|
2390 ug/mL
Geometric Coefficient of Variation 23
|
—
|
Adverse Events
Pooled Placebo IV
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
700 mg LY3832479 IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
2800 mg LY3832479 IV
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
7000 mg LY3832479 IV
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Pooled Placebo IV
n=6 participants at risk
Participants received single Intravenous (IV) dose of Placebo.
|
700 mg LY3832479 IV
n=7 participants at risk
Participants received single IV dose of 700 mg LY3832479.
|
2800 mg LY3832479 IV
n=7 participants at risk
Participants received single IV dose of 2800 mg LY3832479.
|
7000 mg LY3832479 IV
n=6 participants at risk
Participants received single IV dose of 7000 mg LY3832479.
|
|---|---|---|---|---|
|
Infections and infestations
Covid-19
|
16.7%
1/6 • Number of events 1 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
16.7%
1/6 • Number of events 1 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Investigations
Sars-cov-2 test positive
|
0.00%
0/6 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Number of events 2 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 2 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Number of events 1 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline, upto 3 Months
All randomized participants who received at least one dose of study drug.
|
0.00%
0/6 • Baseline, upto 3 Months
All randomized 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