Test of LY4302814 in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional study in healthy participants designed to evaluate tolerability and safety of LY4302814. Participants will undergo limited clinical monitoring, blood tests, and at least one overnight stay in a clinical research unit, with treatment periods spanning up to about 6 months. The study compares LY4302814 to placebo across multiple administration cohorts to characterize pharmacokinetics and pharmacodynamics in normal-health volunteers. Locations include a Research Unit in Daytona Beach, FL and a pharmacology center in Singapore. Eligibility requires being healthy with normal labs, meeting weight and BMI criteria, and appropriate sex- and pregnancy-related eligibility according to local regulations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Are overtly healthy as determined by medical evaluation.
* Have clinical laboratory test results within the normal range for the population or investigative site or with abnormalities deemed not clinically significant by the investigator.
* Have a body weight of 45 kilograms (kg) or greater and body mass index within 18 to 32 kilogram per square meter (kg/m ²), inclusive.
* Are individuals assigned female at birth (AFAB) and not of childbearing potential, and individuals assigned male at birth (AMAB). Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
* Adult participants in Singapore:

  * Are 21 years of age or older.

Exclusion Criteria:

* Evidence or history of clinically significant conditions.
* Have a 12-lead electrocardiogram (ECG) abnormality, that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis.
* Show evidence of hepatitis B virus (HBV) infection with a positive hepatitis B surface antigen (HBsAg) or anti-hepatitis B core (HBc).
* Show evidence of hepatitis C virus (HCV) infection, with positive anti-HCV.
* Have human immunodeficiency virus (HIV) infection or positive HIV-1 and HIV-2 antibodies.
* Have used or intend to use herbal, vitamin supplements, over-the-counter or prescription medication, within 14 days or 5 half-lives (whichever is longer) prior to dosing and during the study, unless, in the opinion of the investigator and sponsor, the medication will not interfere with the study.
* Smoke more than 5 cigarettes a day, or the equivalent in nicotine-containing products, and/or are unable to abide by clinical research unit (CRU) smoking restrictions.
* Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator.

Where it's running

• Fortrea Clinical Research Unit
  Daytona Beach, Florida, United States Recruiting
• Lilly Centre for Clinical Pharmacology
  Singapore, Singapore Recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.