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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3832479; Drug: Placebo

• Registration Number: NCT04441931
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-06-19
• Study First Submitted: 2020-06-19
• Study First Submitted QC: 2020-06-19
• Study First Posted: 2020-06-22
• Primary Completion: 2020-10-02
• Study Completion: 2020-10-02
• Status Verified: 2021-11
• Results First Submitted: 2021-11-01
• Results First Submitted QC: 2021-11-01
• Last Update Submitted: 2021-11-01
• Results First Posted: 2021-12-06
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Are overtly healthy as determined by medical evaluation including medical history and physical examination

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LY3832479	LY3832479	Participants received single Intravenous (IV) doses of 700, 2800 and 7000 milligrams (mg) LY3832479.
Placebo	Placebo	Participants received single IV dose of Placebo.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug	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

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479	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	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.

Trial Locations

Locations (1)

Covance Clinical Research Inc; 🇺🇸 Daytona Beach, Florida, United States