NCT07535099

Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy Subjects

A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Doses of ICP-538 in Healthy Participants

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy Subjects

Conditions

• Health Services Research

Interventions

Type	Name	Description
DRUG	ICP-538 Tablets	ICP-538 will be administered as tablet
DRUG	ICP-538 placebo Tablets	Matching placebo will be administered as tablet

Timeline

• Start date: 2026-03-13
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

1 site across 1 country: China