NCT06311656

A Study to Evaluate Safety, Tolerability of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants

A Placebo-controlled, Phase 1, Participant- and Investigator-blinded, Single- and Multiple- Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of LY4100511 (DC-853) in Healthy Asian and Non-Asian Participants

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The main purpose of this study is to assess the safety and tolerability of LY4100511 (DC-853) after single and multiple dose administrations in healthy asian participants and non-Asian participants. Part A consists of 2 groups and Part B, C, and D include optional groups.

Detailed description

Part B and C added per protocol amendment (May 2024) Added Part B to explore higher dose levels and Part C to explore effects of food. Part D added per protocol amendment (June 2024) to explore higher multiple doses.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	LY4100511 (DC-853)	Administered orally fasted
DRUG	LY4100511 (DC-853)	Administered orally fasted.
DRUG	LY4100511 (DC-853)	Administered orally fed and fasted.
DRUG	LY4100511 (DC-853)	Administered orally fed and fasted.
DRUG	Placebo	Administered orally.

Timeline

• Start date: 2024-03-19
• Primary completion: 2024-10-04
• Completion: 2024-10-04
• First posted: 2024-03-15
• Last updated: 2025-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study