A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of DC-853 in Healthy Participants
A Phase I, Randomized, Double-Blinded, Placebo-Controlled, 2-Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single Ascending and Multiple Ascending Doses of DC-853 in Healthy Participants
3 other identifiers
interventional
88
1 country
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 participants. Participation could last up to 7 weeks
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 healthy
Started Feb 2023
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2023
CompletedFirst Submitted
Initial submission to the registry
April 15, 2025
CompletedFirst Posted
Study publicly available on registry
April 22, 2025
CompletedApril 22, 2025
April 1, 2025
9 months
April 15, 2025
April 15, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Part 1
Baseline up to 6 Days
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Part 2
Baseline up to 7 Days
Study Arms (2)
LY4100511 (DC-853) Part 1
EXPERIMENTALSingle doses of LY4100511 (DC-853) administered orally.
LY4100511 (DC-853) Part 2
EXPERIMENTALMultiple doses of LY4100511 (DC-853) administered orally.
Interventions
Administered orally
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Medicines Evaluation Unit Ltd.
Manchester, M23 (QZ, United Kingdom
Study Officials
- 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 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
April 15, 2025
First Posted
April 22, 2025
Study Start
February 13, 2023
Primary Completion
October 30, 2023
Study Completion
October 30, 2023
Last Updated
April 22, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share