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

February 21, 2025 updated by: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cypress, California, United States, 90630
        • Altasciences Clinical Los Angeles, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered orally.
Drug: Placebo
Administered orally.
Experimental: LY4100511 (DC-853) Part A Fasted
Single and multiple doses of LY4100511 (DC-853) administered orally.
Drug: LY4100511 (DC-853)
Administered orally fasted
Drug: LY4100511 (DC-853)
Administered orally fasted.
Drug: LY4100511 (DC-853)
Administered orally fed and fasted.
Experimental: LY4100511 (DC-853) Part B
Single and multiple higher doses of LY4100511 (DC-853) administered orally.
Drug: LY4100511 (DC-853)
Administered orally fasted
Drug: LY4100511 (DC-853)
Administered orally fasted.
Drug: LY4100511 (DC-853)
Administered orally fed and fasted.
Experimental: LY4100511 (DC-853) Part C (Open Label)
Single dose of LY4100511 (DC-853) administered orally in fed and fasted states.
Drug: LY4100511 (DC-853)
Administered orally fasted
Drug: LY4100511 (DC-853)
Administered orally fasted.
Drug: LY4100511 (DC-853)
Administered orally fed and fasted.
Experimental: LY4100511 (DC-853) Part D
Multiple higher doses of LY4100511 (DC-853) administered orally.
Drug: LY4100511 (DC-853)
Administered orally fasted
Drug: LY4100511 (DC-853)
Administered orally fasted.
Drug: LY4100511 (DC-853)
Administered orally fed and fasted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with one or more Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs)
Time Frame: 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.
Baseline up to 47 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company

Collaborators

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2024

Primary Completion (Actual)

October 4, 2024

Study Completion (Actual)

October 4, 2024

Study Registration Dates

First Submitted

March 8, 2024

First Submitted That Met QC Criteria

March 8, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 21, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 18840
  • J5C-MC-FOAA (Other Identifier: DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company)
  • DCE853107 (Other Identifier: DICE Therapeutics, a wholly owned subsidiary of Eli Lilly and Company)

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

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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