Testing ICP-538 safety and dosing in healthy adults.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled Phase 1 study uses single and multiple ascending oral doses of ICP-538 in healthy adult volunteers to characterize safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD). Participants are screened for normal laboratory values, ECG, chest X-ray, abdominal ultrasound, BMI 18–26 kg/m2, minimum weight thresholds, and appropriate reproductive status or contraception. Cohorts receive escalating doses of ICP-538 or matching placebo under blinded conditions with close monitoring for adverse events and timed PK/PD sample collection. Dose escalation is guided by predefined safety rules and conducted at a single site in Beijing.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntarily sign the ICF..
2. BMI between 18-26 kg/m² (inclusive). Male weight ≥50 kg; female weight ≥45 kg.
3. Vital signs, physical examination, ECG, Chest X-ray, Abdominal ultrasound results at screening are within normal range or showing minor deviations deemed not clinically significant by the investigator.
4. Laboratory test results at screening and baseline are within the normal reference range.
5. Reproductive Status：Females of non-childbearing potential . Male participants and their partners must agree to use effective contraception throughout the study and for 3 months after the last dose. Male participants must not donate sperm during this period.

Exclusion Criteria:

1. Evidence or history of clinically significant diseases, or Evidence or history of allergic diseases .
2. Clinically significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption.
3. Acute illness within 14 days before dosing.
4. Severe infection within 6 months before dosing, or chronic/recurrent infections.
5. Participant and/or first-degree relative with hereditary immunodeficiency.
6. Major trauma or surgery within 3 months before dosing.
7. History of active/latent TB or contact with an open TB case within 6 months before dosing.
8. Positive urine drug screen.
9. Alcohol abuse.
10. Use of tobacco/nicotine products within 3 months before the first dose.
11. Use of any prescription/non-prescription drugs, herbal medicines, supplements within 14 days before first dose; or systemic corticosteroids, immunosuppressants/modulators, hormone replacement therapy within 30 days before first dose; or any other factor affecting drug absorption, distribution, metabolism, and excretion.
12. Consumption of caffeine-containing foods/beverages within 48 hours before the first dose.
13. Use of known CYP3A4 inducers/inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose.
14. Dieting, dietary therapy within 30 days before the first dose.
15. Positive for syphilis antibody, HCV-Ab, HBsAg, HBcAb, or HIV-Ab at screening.
16. Administration of live vaccines within 6 weeks before the first dose or planned during study or within 8 weeks after study.

Where it's running

• Beijing Gobroad Hospital
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Quankun Zhuang
• Email: zhuangqk@gobroadhealthcare.com
• Phone: +86-13011825339

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.