A Study of LY3819253 (LY-CoV555) in Healthy Participants

The purpose of this study is to test the safety and tolerability of LY3819253 when it is given by injection just under the skin to healthy participants. Blood tests will be done to check how much LY3819253 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.

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Key information

Conditions

Healthy

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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])

Treatment and study plan

LY3819253

Drug

Administered SC.

Other names: LY-CoV555, Bamlanivimab

Placebo

Drug

Administered SC.

Primary outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819253

Time frame: Days 1, 2, 3, 4, 5, 6, 7, 15, 29, 60, 85 post-dose

PK: AUC[0-∞] of LY3819253

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized, Placebo-Controlled, Participant- and Investigator-Blind, Phase 1 Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of LY3819253 Administered Subcutaneously to Healthy Participants

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Sep 3, 2020
Registry last updated: Dec 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed