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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
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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
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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
Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3832479
LY3832479 administered intravenously (IV).
 Drug: LY3832479
Administered IV.
Other Name: LY-CoV016
Placebo Comparator: Placebo
Placebo administered IV.
 Drug: Placebo
Administered IV.


Outcome Measures
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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) ]
    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module


Secondary Outcome Measures :
  1. 2. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3832479 [ Time Frame: Day 1: Pre-dose through Day 85 ]
    PK: AUC of LY3832479

  2. PK: Maximum Concentration (Cmax) of LY3832479 [ Time Frame: Day 1: Pre-dose through Day 85 ]
    PK: Cmax of LY3832479


Eligibility Criteria
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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
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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


Locations
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United States, Florida
Covance Clinical Research Inc
Daytona Beach, Florida, United States, 32117
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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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
Last Update Posted: October 8, 2020
Last Verified: October 2020
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