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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY3819253; Drug: Placebo

• Registration Number: NCT04537910
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-09-01
• Study First Submitted QC: 2020-09-01
• Study Start: 2020-09-02
• Study First Posted: 2020-09-03
• Primary Completion: 2020-12-28
• Study Completion: 2020-12-28
• Status Verified: 2021-11
• Results First Submitted: 2021-11-01
• Results First Submitted QC: 2021-11-01
• Last Update Submitted: 2021-11-01
• Results First Posted: 2021-12-06
• Last Update Posted: 2021-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Read More

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])

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3819253	LY3819253	Participants received single subcutaneous (SC) doses of 150 milligram (mg), 350 mg or 700 mg LY3819253.
Placebo	Placebo	Participants received a single SC dose of Placebo.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Covance Clinical Research Inc; 🇺🇸 Daytona Beach, Florida, United States