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Trial record 2 of 4 for:    LY3832479

A Study of LY3832479 (LY-CoV016) in Healthy Participants 1

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ClinicalTrials.gov Identifier: NCT04611789
Recruitment Status : Completed
First Posted : November 2, 2020
Last Update Posted : February 18, 2021
Sponsor:
Collaborator:
Shanghai Junshi Bioscience Co., Ltd.
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to test the safety and tolerability of LY3832479 when it is given by injection just under the skin to healthy participants. Blood tests will be done to check how much LY3832479 is in the bloodstream and how long the body takes to eliminate it. Participation could last up to 16 weeks and may include up to six visits to the study center, with a one-week overnight stay.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Placebo-Controlled, Participant- and Investigator-Blind, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of LY3832479 Administered Subcutaneously to Healthy Participants
Actual Study Start Date : November 2, 2020
Actual Primary Completion Date : February 10, 2021
Actual Study Completion Date : February 10, 2021

Arm Intervention/treatment
Experimental: LY3832479
LY3832479 administered subcutaneously (SC).
Drug: LY3832479
LY3832479 administered SC.
Other Names:
  • LY-CoV016
  • Etesevimab

Placebo Comparator: Placebo
Placebo administered SC.
Drug: Placebo
Placebo administered SC.




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time 0 to Infinity (AUC[0-inf]) of LY3832479 [ Time Frame: Day 1 through Day 85 ]
    PK: AUC(0-inf)

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

Inclusion Criteria:

  • Are overtly healthy as determined by medical evaluation including medical history and physical examination
  • Are willing to follow study procedures, including having nasal or nasopharyngeal swabs collected
  • Have a body mass index (BMI) within the range of greater than or equal to (≥)18.5 to less than (<)35 kilograms per square meter (kg/m²)
  • Male participants must agree to adhere to contraception restrictions
  • Female participants must be of non-childbearing potential

Exclusion Criteria:

  • Have or have had known or suspected severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection
  • Have a history or presence of cardiovascular (including hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological disorders that, in the opinion of the investigator, are capable of

    • Significantly altering the absorption, metabolism, or elimination of drugs
    • Constituting a risk while taking the investigational product, or
    • Interfering with the interpretation of data
  • Have significant allergies to humanized monoclonal antibodies (mAbs)
  • Have any of the following that are clinically significant:

    • Multiple or severe drug allergies, or
    • Intolerance to topical corticosteroids, or
    • Severe posttreatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis)
  • Have had lymphoma, leukemia, or any malignancy within the past 5 years, except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
  • Have had breast cancer within the past 10 years
  • Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
  • Show evidence of current hepatitis C (that is, test positive for anti-hepatitis C antibody with confirmed presence of hepatitis C virus [HCV] ribonucleic acid [RNA])

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): NCT04611789


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
Shanghai Junshi Bioscience Co., Ltd.
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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04611789    
Other Study ID Numbers: 18154
J2Z-MC-PGAB ( Other Identifier: Eli Lilly and Company )
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: February 18, 2021
Last Verified: February 15, 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
Product Manufactured in and Exported from the U.S.: Yes