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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04611789
• Other study ID #: 18154
• Secondary ID: J2Z-MC-PGAB
• Status: Completed
• Phase: Phase 1
• Start date: November 2, 2020
• Est. completion date: February 10, 2021

Study information

• Verified date: November 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: February 10, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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])

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY3832479
Administered subcutaneously
• Placebo
Administered subcutaneously

Locations

Country	Name	City	State
United States	Covance Clinical Research Inc	Daytona Beach	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Shanghai Junshi Bioscience Co., Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Tlast (AUC[0-tlast]) of LY3832479	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time 0 to tlast (AUC[0-tlast]) of LY3832479.	Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose
Primary	PK: Maximum Serum Concentration (Cmax) of LY3832479	PK: Maximum Serum Concentration (Cmax) of LY3832479.	Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose