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

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Lilly

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Drug: LY4100511

Study type

Interventional

Funder types

Industry

Identifiers

NCT06937411
2022-003220-40 (EudraCT Number)
18880
J5C-MC-FOAD (Other Identifier)

Details and patient eligibility

About

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

Enrollment

88 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

88 participants in 2 patient groups

LY4100511 (DC-853) Part 1
Experimental group
Description:
Single doses of LY4100511 (DC-853) administered orally.
Treatment:
Drug: LY4100511
LY4100511 (DC-853) Part 2
Experimental group
Description:
Multiple doses of LY4100511 (DC-853) administered orally.
Treatment:
Drug: LY4100511

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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