Phase 1
Completed N=26
A Study of LY3832479 (LY-CoV016) in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT04441931 ↗
Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug — 0; 0; 0; 0 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug |
0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479 |
4920; 22700; 50800 | — |
| SECONDARY PK: Maximum Serum Concentration (Cmax) of LY3832479 |
244; 1130; 2390 | — |
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
Data sourced from ClinicalTrials.gov (NCT04441931). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.