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

• ClinicalTrials.gov Identifier: NCT04441931
• Recruitment Status: Completed
• First Posted: June 22, 2020
• Results First Posted: December 6, 2021
• Last Update Posted: December 6, 2021
• Sponsor: Eli Lilly and Company
• Information provided by (Responsible Party): Eli Lilly and Company

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, Florida

Covance Clinical Research Inc

Daytona Beach, Florida, United States, 32117

Sponsors and Collaborators

Eli Lilly and Company

Investigators

• 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

More Information

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

Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9:CD013825. doi: 10.1002/14651858.CD013825.pub2. Review.

• 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
• 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