- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04611789
A Study of LY3832479 (LY-CoV016) in Healthy Participants 1
November 1, 2021 updated by: Eli Lilly and Company
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Daytona Beach, Florida, United States, 32117
- Covance Clinical Research Inc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LY3832479
Participants received single subcutaneous dose of 350 milligrams (mg) and 1000 mg LY3832479.
|
Administered subcutaneously
Other Names:
|
Placebo Comparator: Placebo
Participants received single subcutaneous dose of Placebo.
|
Administered subcutaneously
|
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 0 to Tlast (AUC[0-tlast]) of LY3832479
Time Frame: Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose
|
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
Time Frame: Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose
|
PK: Maximum Serum Concentration (Cmax) of LY3832479.
|
Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 2, 2020
Primary Completion (Actual)
February 10, 2021
Study Completion (Actual)
February 10, 2021
Study Registration Dates
First Submitted
October 30, 2020
First Submitted That Met QC Criteria
October 30, 2020
First Posted (Actual)
November 2, 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
Other Study ID Numbers
- 18154
- J2Z-MC-PGAB (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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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