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A Study of LY3832479 (LY-CoV016) in Healthy Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04441931
Recruitment Status : Completed
First Posted : June 22, 2020
Results First Posted : December 6, 2021
Last Update Posted : December 6, 2021
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to learn more about the safety of LY3832479 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3832479 is in the bloodstream and how long it takes the body to eliminate it. Participation could last up to 16 weeks and may include up to 10 visits to the study center.

Condition or disease Intervention/treatment Phase
Healthy Drug: LY3832479 Drug: Placebo Phase 1

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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.
Drug: LY3832479
Administered IV.
Other Name: LY-CoV016

Placebo Comparator: Placebo
Participants received single IV dose of Placebo.
Drug: Placebo
Administered IV.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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

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United States, Florida
Covance Clinical Research Inc
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Eli Lilly and Company
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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
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] July 15, 2020
Statistical Analysis Plan  [PDF] July 24, 2020

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No