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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06311656
• Other study ID #: 18840
• Secondary ID: J5C-MC-FOAA
• Status: Recruiting
• Phase: Phase 1
• Start date: March 19, 2024
• Est. completion date: July 30, 2024

Study information

• Verified date: May 2024
• Source: DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
• Contact: This is a single site clinical trial 1-877-CTLILLY (1-877-285-45
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and C include optional groups.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 59
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• LY4100511 (DC-853)
Administered orally fasted
• Placebo
Administered orally.
• LY4100511 (DC-853)
Administered orally fed and fasted

Locations

Country	Name	City	State
United States	Altasciences Clinical Los Angeles, Inc	Cypress	California

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4100511 (DC-853)		Predose up to 47 days
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4100511 (DC-853)		Predose up to 47 days