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

A Phase I, Randomized, Double-Blinded, Placebo-Controlled, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending and Multiple Ascending Doses of DC-853 in Healthy Participants

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: LY4100511

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M23 (QZ
    • The Medicines Evaluation Unit Ltd.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY4100511 (DC-853) Part 1; Single doses of LY4100511 (DC-853) administered orally.	Drug: LY4100511; Administered orally; Other Names: DC-853
Experimental: LY4100511 (DC-853) Part 2; Multiple doses of LY4100511 (DC-853) administered orally.	Drug: LY4100511; Administered orally; Other Names: DC-853

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: April 15, 2025
• First Submitted That Met QC Criteria: April 15, 2025
• First Posted (Actual): April 22, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 18880; J5C-MC-FOAD (Other Identifier: Eli Lilly and Company); 2022-003220-40 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No