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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-13

Study Completion Date

2023-10-30

Brief Summary

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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

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY4100511 (DC-853) Part 1

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

Group Type EXPERIMENTAL

LY4100511

Intervention Type DRUG

Administered orally

LY4100511 (DC-853) Part 2

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

Group Type EXPERIMENTAL

LY4100511

Intervention Type DRUG

Administered orally

Interventions

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LY4100511

Administered orally

Intervention Type DRUG

Other Intervention Names

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DC-853

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes