A Phase 1, Randomized, Placebo-Controlled, Investigator and Participant Blinded, Single Ascending Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4302814 in Healthy Participants
Eli Lilly and Company
Summary
The main purpose of this study is to assess how well LY4302814 is tolerated and what side effects may occur in healthy participants. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last about 6 months and will include at least one overnight stay in the clinical research unit (CRU) lasting up to approximately 9 days.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
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 regu…
Interventions
- DrugLY4302814
Administered SC
- DrugLY4302814
Administered IV
- DrugPlacebo
Administered SC
- DrugPlacebo
Administered IV
Locations (2)
- Fortrea Clinical Research UnitDaytona Beach, Florida
- Lilly Centre for Clinical PharmacologySingapore