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

NCT06311656 | Completed Phase 1 FDA Drug

• 3 other identifiers: 18840J5C-MC-FOAADCE853107
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of participants with one or more Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs)

  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 Outcomes (2)

• 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

Study Arms (5)

LY4100511 (DC-853) Part A Fasted

EXPERIMENTAL

Single and multiple doses of LY4100511 (DC-853) administered orally.

Drug: LY4100511 (DC-853)

LY4100511 (DC-853) Part B

EXPERIMENTAL

Single and multiple higher doses of LY4100511 (DC-853) administered orally.

Drug: LY4100511 (DC-853)

LY4100511 (DC-853) Part C (Open Label)

EXPERIMENTAL

Single dose of LY4100511 (DC-853) administered orally in fed and fasted states.

Drug: LY4100511 (DC-853)

LY4100511 (DC-853) Part D

EXPERIMENTAL

Multiple higher doses of LY4100511 (DC-853) administered orally.

Drug: LY4100511 (DC-853)

Placebo

PLACEBO COMPARATOR

Placebo administered orally.

Drug: Placebo

Interventions

LY4100511 (DC-853) DRUG

Administered orally fasted

LY4100511 (DC-853) Part A Fasted

Placebo DRUG

Administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Altasciences Clinical Los Angeles, Inc

Cypress, California, 90630, United States

Location

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 15, 2024
• Study Start: March 19, 2024
• Primary Completion: October 4, 2024
• Study Completion: October 4, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)