A Study of LY3832479 (LY-CoV016) in Healthy Participants
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|ClinicalTrials.gov Identifier: NCT04441931|
Recruitment Status : Completed
First Posted : June 22, 2020
Results First Posted : December 6, 2021
Last Update Posted : December 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: LY3832479 Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Immunogenicity of LY3832479 Given as a Single Intravenous Dose in Healthy Participants|
|Actual Study Start Date :||June 19, 2020|
|Actual Primary Completion Date :||October 2, 2020|
|Actual Study Completion Date :||October 2, 2020|
Participants received single Intravenous (IV) doses of 700, 2800 and 7000 milligrams (mg) LY3832479.
Other Name: LY-CoV016
Placebo Comparator: Placebo
Participants received single IV dose of Placebo.
- Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug [ Time Frame: Baseline through Follow-up (Week 12) ]The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479 [ Time Frame: Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85 ]Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to infinity (AUC[0-∞]) of LY3832479.
- PK: Maximum Serum Concentration (Cmax) of LY3832479 [ Time Frame: Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85 ]PK: Maximum Serum Concentration (Cmax) of LY3832479.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04441931
|United States, Florida|
|Covance Clinical Research Inc|
|Daytona Beach, Florida, United States, 32117|
|Study Director:||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|