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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY4100511 (DC-853); Drug: Placebo

• Registration Number: NCT06311656
• Lead Sponsor: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

Brief 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.

Study Timeline

• Study First Submitted: 2024-03-08
• Study First Submitted QC: 2024-03-08
• Study First Posted: 2024-03-15
• Study Start: 2024-03-19
• Primary Completion: 2024-10-04
• Study Completion: 2024-10-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Male and female participants who are overtly healthy as determined by medical history, vital signs, and physical examination.
• Participants of Japanese, Chinese, and Non-Asian ethnicities
• Have a body mass index within the range of 18.0 to 32 kilograms per square meter (kg/m²). For healthy Japanese participants, have a body mass index of 18.0 to 28.0 kg/m²
• Have venous access sufficient to allow for blood sampling
• Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Exclusion Criteria

• Have a current or recent acute, active infection
• Had any surgical procedure within 12 weeks prior to study
• Are immunocompromised
• Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values
• Are currently enrolled in a clinical study involving any experimental antibody or biologic therapy within the previous 6 months, or any other experimental therapy within 30 days before the first dose of the study intervention or during the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LY4100511 (DC-853) Part B	LY4100511 (DC-853)	Single and multiple higher doses of LY4100511 (DC-853) administered orally.
LY4100511 (DC-853) Part C (Open Label)	LY4100511 (DC-853)	Single dose of LY4100511 (DC-853) administered orally in fed and fasted states.
LY4100511 (DC-853) Part D	LY4100511 (DC-853)	Multiple higher doses of LY4100511 (DC-853) administered orally.
Placebo	Placebo	Placebo administered orally.
LY4100511 (DC-853) Part A Fasted	LY4100511 (DC-853)	Single and multiple doses of LY4100511 (DC-853) administered orally.

Primary Outcome Measures

Name	Time	Method
Number of participants with one or more Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs)	Baseline up to 47 days	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4100511 (DC-853)	Predose up to 47 days
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4100511 (DC-853)	Predose up to 47 days

Trial Locations

Locations (1)

Altasciences Clinical Los Angeles, Inc; 🇺🇸 Cypress, California, United States