NCT04611789

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

November 2, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 10, 2021

Completed
10 months until next milestone

Results Posted

Study results publicly available

December 6, 2021

Completed
Last Updated

December 6, 2021

Status Verified

November 1, 2021

Enrollment Period

3 months

First QC Date

October 30, 2020

Results QC Date

November 1, 2021

Last Update Submit

November 1, 2021

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (2)

LY3832479

EXPERIMENTAL

Participants received single subcutaneous dose of 350 milligrams (mg) and 1000 mg LY3832479.

Drug: LY3832479

Placebo

PLACEBO COMPARATOR

Participants received single subcutaneous dose of Placebo.

Drug: Placebo

Interventions

LY3832479DRUG

Administered subcutaneously

Also known as: LY-CoV016, Etesevimab
LY3832479
PlaceboDRUG

Administered subcutaneously

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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 \[RNA\])

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

etesevimab

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2020

First Posted

November 2, 2020

Study Start

November 2, 2020

Primary Completion

February 10, 2021

Study Completion

February 10, 2021

Last Updated

December 6, 2021

Results First Posted

December 6, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)