Trial Outcomes & Findings for A Study of LY3819253 (LY-CoV555) in Healthy Participants (NCT NCT04537910)
NCT ID: NCT04537910
Last Updated: 2021-12-06
Results Overview
PK: AUC\[0-∞\] of LY3819253
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
25 participants
Primary outcome timeframe
Days 1, 2, 3, 4, 5, 6, 7, 15, 29, 60, 85 post-dose
Results posted on
2021-12-06
Participant Flow
Participant milestones
| Measure |
Placebo SC
Participants received a single subcutaneous (SC) dose of Placebo.
|
150 Milligram (mg) LY3819253 SC
Participants received a single SC dose of 150 mg LY3819253.
|
350 mg LY3819253 SC
Participants received a single SC dose of 350 mg LY3819253.
|
700 mg LY3819253 SC
Participants received a single SC dose of 700 mg LY3819253.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
5
|
7
|
7
|
|
Overall Study
Received at Least One Dose of Study Drug
|
6
|
5
|
7
|
7
|
|
Overall Study
COMPLETED
|
6
|
5
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of LY3819253 (LY-CoV555) in Healthy Participants
Baseline characteristics by cohort
| Measure |
Placebo SC
n=6 Participants
Participants received a single SC dose of Placebo.
|
150 mg LY3819253 SC
n=5 Participants
Participants received a single SC dose of 150 mg LY3819253.
|
350 mg LY3819253 SC
n=7 Participants
Participants received a single SC dose of 350 mg LY3819253.
|
700 mg LY3819253 SC
n=7 Participants
Participants received a single SC dose of 700 mg LY3819253.
|
Total
n=25 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
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
25 Participants
n=21 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
|
|
Age, Continuous
|
47.3 years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
46.0 years
STANDARD_DEVIATION 16 • n=7 Participants
|
45.6 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
41.4 years
STANDARD_DEVIATION 9.2 • n=4 Participants
|
44.9 years
STANDARD_DEVIATION 11.2 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 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
|
|
Race (NIH/OMB)
Asian
|
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
|
|
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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
17 Participants
n=21 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
|
|
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
|
|
Region of Enrollment
United States
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Days 1, 2, 3, 4, 5, 6, 7, 15, 29, 60, 85 post-dosePopulation: All randomized participants who received at least one dose of LY3819253 and had evaluable PK data.
PK: AUC\[0-∞\] of LY3819253
Outcome measures
| Measure |
150 mg LY3819253 SC
n=1 Participants
Participants received a single SC dose of 150 mg LY3819253.
|
350 mg LY3819253 SC
n=3 Participants
Participants received a single SC dose of 350 mg LY3819253.
|
700 mg LY3819253 SC
n=3 Participants
Participants received a single SC dose of 700 mg LY3819253.
|
|---|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819253
|
NA micrograms*day per milliliter(μg*day/mL)
Geometric Coefficient of Variation NA
Geometric Mean and Geometric Coefficient of Variation couldn't be calculated as there was only one participant. Individual value reported: 259 μg\*day/mL
|
918 micrograms*day per milliliter(μg*day/mL)
Geometric Coefficient of Variation 15
|
1390 micrograms*day per milliliter(μg*day/mL)
Geometric Coefficient of Variation 34
|
Adverse Events
Placebo SC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
150 mg LY3819253 SC
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
350 mg LY3819253 SC
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
700 mg LY3819253 SC
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 |
Placebo SC
n=6 participants at risk
Participants received a single SC dose of Placebo.
|
150 mg LY3819253 SC
n=5 participants at risk
Participants received a single SC dose of 150 mg LY3819253.
|
350 mg LY3819253 SC
n=7 participants at risk
Participants received a single SC dose of 350 mg LY3819253.
|
700 mg LY3819253 SC
n=7 participants at risk
Participants received a single SC dose of 700 mg LY3819253.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/6 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • Number of events 1 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
16.7%
1/6 • Number of events 1 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
16.7%
1/6 • Number of events 1 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/5 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
20.0%
1/5 • Number of events 1 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
0.00%
0/7 • Baseline to Follow-up (up to 85 days)
All randomized participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Neither Lilly or Supplier shall publish, discuss, or release data emanating from a study without the other party's express written permission which shall not be unreasonably withheld. Nothing herein shall limit supplier's right to respond to legal inquiries.
- Publication restrictions are in place
Restriction type: OTHER