NCT06395012

A First-In-Human Study of LY3985297 in Healthy Participants

A Phase 1, Randomized, Placebo-controlled, Investigator and Participant Blinded, Single Ascending Dose and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY3985297 in Healthy Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to see if LY3985297, the study drug, is safe and well-tolerated when given as a single dose or as multiple doses either through an intravenous (into a vein) or a subcutaneous (under the skin) injection in healthy participants. Study will also evaluate how much of the study drug LY3985297 gets into the blood stream and how long it takes the body to remove it. The study is conducted in two parts (part A and B), each part has a separate treatment cohort. The study will last up to approximately 116 days for part A, and 145 days for part B, including the screening period.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LY3985297	Administered either IV or SC.
DRUG	Placebo	Administered either IV or SC.

Timeline

• Start date: 2024-06-07
• Primary completion: 2025-08-06
• Completion: 2025-08-06
• First posted: 2024-05-01
• Last updated: 2025-09-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study