Trial Profile

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 of Trial: Phase I

Latest Information Update: 21 Apr 2026

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At a glance

Drugs ICP 538 (Primary)
Indications Autoimmune disorders; Inflammatory bowel diseases; Multiple sclerosis; Systemic lupus erythematosus
Focus Adverse reactions
Sponsors InnoCare Pharma

15 Mar 2026 According to InnoCare media release, company announced that the first healthy volunteer has been dosed in a clinical trial of ICP-538.
18 Feb 2026 New trial record
09 Feb 2026 According to InnoCare media release, company announced today that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application to conduct clinical trials of ICP-538.

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