NCT07522970

A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LG-0317 in Healthy Participants

A Randomized, Single and Multiple Ascending Doses, Food-effect Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LG-0317 Tablets in Healthy Chinese Participants

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: LinGang Laboratory · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This study is the first administration of LG-0317 to humans. The purpose of the study is to evaluate safety/tolerability and pharmacokinetics in healthy subjects. The intention of this study is to provide confidence in the safety of the molecule to inform progression to further proof-of-concept studies.

Detailed description

This study consists of three parts: single ascending dose, food effect , and multiple ascending dose. The single ascending dose part consists of a screening period (4 weeks), a dosing observation period and a follow-up period. Participants in different dose groups will be enrolled sequentially according to the dose escalation principle. In the food effect part, eligible participants will be randomly assigned to Sequence 1 or Sequence 2 prior to dosing in the first period. Participants will receive a single oral dose of LG-0317 tablet either under fasting conditions or after a high-fat, high-calorie meal, depending on their assigned sequence. The multiple ascending dose part will include 3-4 dose groups, and the dose levels will be determined based on the safety, tolerability, and available PK and PD data obtained from the single ascending dose part.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	LG-0317	Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses
DRUG	Placebo	Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses

Timeline

• Start date: 2026-04-14
• Primary completion: 2026-09-10
• Completion: 2026-09-10
• First posted: 2026-04-13
• Last updated: 2026-04-13