A Study of LY3832479 (LY-CoV016) in Healthy Participants
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ClinicalTrials.gov Identifier: NCT04441931 |
Recruitment Status :
Completed
First Posted : June 22, 2020
Results First Posted : December 6, 2021
Last Update Posted : December 6, 2021
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Condition or disease | Intervention/treatment | Phase |
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Healthy | Drug: LY3832479 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Sequential Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Immunogenicity of LY3832479 Given as a Single Intravenous Dose in Healthy Participants |
Actual Study Start Date : | June 19, 2020 |
Actual Primary Completion Date : | October 2, 2020 |
Actual Study Completion Date : | October 2, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: LY3832479
Participants received single Intravenous (IV) doses of 700, 2800 and 7000 milligrams (mg) LY3832479.
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Drug: LY3832479
Administered IV.
Other Name: LY-CoV016 |
Placebo Comparator: Placebo
Participants received single IV dose of Placebo.
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Drug: Placebo
Administered IV. |
- Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug [ Time Frame: Baseline through Follow-up (Week 12) ]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.
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479 [ Time Frame: Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85 ]Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to infinity (AUC[0-∞]) of LY3832479.
- PK: Maximum Serum Concentration (Cmax) of LY3832479 [ Time Frame: Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85 ]PK: Maximum Serum Concentration (Cmax) of LY3832479.

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Are overtly healthy as determined by medical evaluation including medical history and physical examination
Exclusion Criteria:
- Test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
- Pregnant women and women of childbearing potential
- Have a history or presence of cardiovascular (including hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders that, in the opinion of the investigator, are capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk while taking the investigational product, or of interfering with the interpretation of data
- Have participated in a clinical study involving an investigational product, with last dose within the past 30 days or 5 half-lives (whichever is longer) prior to dosing

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04441931
United States, Florida | |
Covance Clinical Research Inc | |
Daytona Beach, Florida, United States, 32117 |
Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Documents provided by Eli Lilly and Company:
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT04441931 |
Other Study ID Numbers: |
18029 J2Z-MC-PGAA ( Other Identifier: Eli Lilly and Company ) |
First Posted: | June 22, 2020 Key Record Dates |
Results First Posted: | December 6, 2021 |
Last Update Posted: | December 6, 2021 |
Last Verified: | November 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |