A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single- and Multiple-Ascending Dose Study to Characterize the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4088044 in Healthy Participants.
Eli Lilly and Company
Summary
The purpose of this study is to evaluate how well LY4088044 is tolerated and what side effects may occur in healthy participants. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4088044 gets into the bloodstream and how long it takes the body to eliminate it. The study will last up to approximately 92 weeks for Parts A, B, and C, excluding screening.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and cardiac monitoring * Have a body mass index (BMI) within the range 18.5 to 30 kilogram per square meter (kg/m²) Exclusion Criteria: * Are individuals assigned female at birth (AFAB) who are pregnant and/or lactating * Regularly use known drugs of abuse or show positive findings on urinary drug screening that are not consistent with their medication history * Participants with hemoglobin outside of the local laboratory normal range…
Interventions
- DrugLY4088044
Administered IV
- DrugLY4088044
Administered SC
- DrugPlacebo
Administered IV
- DrugPlacebo
Administered SC
Locations (6)
- Collaborative Neuroscience Network - CNSLos Alamitos, California
- ICONLenexa, Kansas
- ICON Early Phase ServicesSan Antonio, Texas
- ICONSalt Lake City, Utah
- New Zealand Clinical Research ChristchurchChristchurch
- Lilly Centre for Clinical PharmacologySingapore