A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of DC-853 in Healthy Participants

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: LY4100511

• Registration Number: NCT06937411
• Lead Sponsor: 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 participants.

Participation could last up to 7 weeks

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-13
• Primary Completion: 2023-10-30
• Study Completion: 2023-10-30
• Status Verified: 2025-04
• Study First Submitted: 2025-04-15
• Study First Submitted QC: 2025-04-15
• Last Update Submitted: 2025-04-15
• Study First Posted: 2025-04-22
• Last Update Posted: 2025-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Participants must be able to understand and comply with the requirements of the study, as judged by the Investigator.
• Participants must have a body mass index (BMI) ≥ 18 and ≤ 35 kilograms per meter squared (kg/m2).

Exclusion Criteria

• History or presence of any clinically relevant acute or chronic medical or psychiatric condition that could interfere with the participant's safety during the clinical study or expose the participant to undue risk as judged by the Investigator.
• Malignancy within the past 5 years of screening with the exception of in situ removal of basal cell carcinoma, resected benign colonic polyps, or adequately treated cervix carcinoma in-situ.
• Planned major surgery within duration of the study or the 30 days following study completion.
• Females who are pregnant, breast feeding, lactating or plan to be pregnant during the study period or 90 days after.
• History of any drug and/or alcohol abuse in the past 2 years prior to screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
LY4100511 (DC-853) Part 1	LY4100511	Single doses of LY4100511 (DC-853) administered orally.
LY4100511 (DC-853) Part 2	LY4100511	Multiple doses of LY4100511 (DC-853) administered orally.

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Part 1	Baseline up to 6 Days
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Part 2	Baseline up to 7 Days

Trial Locations

Locations (1)

The Medicines Evaluation Unit Ltd.; 🇬🇧 Manchester, United Kingdom