Clinical trial NCT04441931: A Study of LY3832479 (LY-CoV016) in Healthy Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-06-22
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to learn more about the safety of LY3832479 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3832479 is in the bloodstream and how long it takes the body to eliminate it. Participation could last up to 16 weeks and may include up to 10 visits to the study center.


Eligibility criteria: Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation including medical history and physical examination

Exclusion Criteria:

* Test positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
* Pregnant women and women of childbearing potential
* Have a history or presence of cardiovascular (including hypertension), respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders that, in the opinion of the investigator, are capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk while taking the investigational product, or of interfering with the interpretation of data
* Have participated in a clinical study involving an investigational product, with last dose within the past 30 days or 5 half-lives (whichever is longer) prior to dosing

Primary outcomes:
measure: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
timeFrame: Baseline through Follow-up (Week 12)
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479
timeFrame: Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85
measure: PK: Maximum Serum Concentration (Cmax) of LY3832479
timeFrame: Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Inc
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References:
citation: Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.