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

Lilly

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: LY3832479; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04441931

18029

J2Z-MC-PGAA (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

---

26 participants in 2 patient groups, including a placebo group

LY3832479

Experimental group

Description:

Participants received single Intravenous (IV) doses of 700, 2800 and 7000 milligrams (mg) LY3832479.

Treatment:

Drug: LY3832479

Placebo

Placebo Comparator group

Description:

Participants received single IV dose of Placebo.

Treatment:

Drug: Placebo