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Completed

NCT Number: NCT06311656

A Study to Evaluate Safety, Tolerability 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.

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical Los Angeles, Inc

Cypress, California, 90630, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY4100511 (DC-853)

Drug

Administered orally fasted

Placebo

Drug

Administered orally.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4100511 (DC-853)

    Time frame: Predose up to 47 days

  2. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4100511 (DC-853)

    Time frame: Predose up to 47 days

Sponsors and collaborators

Lead sponsor

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

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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