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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: Placebo; Drug: LY3819253

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Covance Clinical Research Inc

Participation Criteria

Eligibility Criteria

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

Description

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])

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants received a single SC dose of Placebo.	Drug: Placebo; Administered SC.
Experimental: LY3819253; Participants received single subcutaneous (SC) doses of 150 milligram (mg), 350 mg or 700 mg LY3819253.	Drug: LY3819253; Administered SC.; Other Names: LY-CoV555; Bamlanivimab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of LY3819253	PK: AUC[0-∞] of LY3819253	Days 1, 2, 3, 4, 5, 6, 7, 15, 29, 60, 85 post-dose

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General 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(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Actual): December 28, 2020
• Study Completion (Actual): December 28, 2020

Study Registration Dates

• First Submitted: September 1, 2020
• First Submitted That Met QC Criteria: September 1, 2020
• First Posted (Actual): September 3, 2020

Study Record Updates

• Last Update Posted (Actual): December 6, 2021
• Last Update Submitted That Met QC Criteria: November 1, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Infective Agents; Antiviral Agents; Bamlanivimab
• Other Study ID Numbers: 18124; J2X-MC-PYAG (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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