Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy Subjects
NCT07535099 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 104
Last updated 2026-04-16
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
- DRUG
-
ICP-538 Tablets
ICP-538 will be administered as tablet
- DRUG
-
ICP-538 placebo Tablets
Matching placebo will be administered as tablet
Sponsors & Collaborators
-
Beijing InnoCare Pharma Tech Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2026-03-13
- Primary Completion
- 2026-09-30
- Completion
- 2026-09-30
Countries
- China
Study Locations
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