A Study of LY4064809 in Healthy Adult Chinese Participants

NCT07247357 | Completed Phase 1

• 2 other identifiers: 27745J6M-MC-JSGE
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to measure how much LY4064809 gets into the bloodstream and how long it takes the body to eliminate it in healthy participants. It also looks at safety and tolerability in healthy participants. The study drug will be administered orally. The study will last approximately 21 days, excluding screening.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY4064809

  PK: Cmax of LY4064809

  Predose on Day 1 Through Day 14

• PK: Area Under the Concentration Versus Time Curve (AUC) of LY4064809

  PK: AUC of LY4064809

  Predose on Day 1 Through Day 14

Study Arms (1)

LY4064809

EXPERIMENTAL

LY4064809 administered orally

Drug: LY4064809

Interventions

LY4064809 DRUG

administered orally

LY4064809

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Are native Chinese. To qualify as a native Chinese for the purpose of this study, all 4 of the participant's biological grandparents must be of exclusive Chinese descent and born in China
• Are overtly healthy as determined by medical evaluation, including medical history, physical examination, vital signs, and electrocardiogram (ECG) at screening and admission
• Have clinical laboratory test results within the normal range for the population or investigative site, or with abnormalities deemed not clinically significant by the investigator at screening
• Have a body mass index within the range 18 to 32 kilogram per square meter (kg/m²)

You may not qualify if:

• History or presence of any of the following conditions, deemed clinically significant by the investigator (or designee), which may significantly alter the absorption, metabolism, or elimination of drugs, constitute a risk when taking the study intervention, or interfere with the data interpretation:
• metabolic disease, including congenital non-hemolytic hyperbilirubinemia, for example, Gilbert syndrome
• bile duct disease, including removal of the gall bladder
• digestive system disease
• blood disease
• disease of the nervous system
• significant history of, or presence of, liver disease, including any abnormal liver function tests, as defined by aspartate aminotransferase, alanine transaminase, or transducin beta-like above the 1.5× upper limit of normal range per the laboratory's reference ranges at screening, or
• clinically significant, active cardiovascular disease or history of heart attack within 6 months prior to the planned start of LY4064809
• Have a 12-lead ECG abnormality at screening or admission
• History of a major surgical procedure within 30 days prior to screening
• Diagnosed or treated cancer within 5 years prior to screening
• Have known allergies to LY4064809 or related compounds

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Scorpion Therapeutics, a wholly owned subsidiary of Eli Lilly and Company: collaborator

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

Location

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: October 24, 2025
• Primary Completion: December 16, 2025
• Study Completion: December 16, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)