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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
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE June 19, 2020
First Posted Date  ICMJE June 22, 2020
Results First Submitted Date  ICMJE November 1, 2021
Results First Posted Date  ICMJE December 6, 2021
Last Update Posted Date December 6, 2021
Actual Study Start Date  ICMJE June 19, 2020
Actual Primary Completion Date October 2, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2021)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2021)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2020)
  • 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
  • PK: Maximum Concentration (Cmax) of LY3832479 [ Time Frame: Day 1: Pre-dose through Day 85 ]
    PK: Cmax of LY3832479
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3832479 (LY-CoV016) in Healthy Participants
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: LY3832479
    Administered IV.
    Other Name: LY-CoV016
  • Drug: Placebo
    Administered IV.
Study Arms  ICMJE
  • Experimental: LY3832479
    Participants received single Intravenous (IV) doses of 700, 2800 and 7000 milligrams (mg) LY3832479.
    Intervention: Drug: LY3832479
  • Placebo Comparator: Placebo
    Participants received single IV dose of Placebo.
    Intervention: Drug: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2020)
26
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2020)
24
Actual Study Completion Date  ICMJE October 2, 2020
Actual Primary Completion Date October 2, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04441931
Other Study ID Numbers  ICMJE 18029
J2Z-MC-PGAA ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Eli Lilly and Company
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Eli Lilly and Company
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP