Testing ICP-538 safety and dosing in healthy adults.

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

This study will test single and multiple doses of the experimental tablet ICP-538 versus placebo to see if it is safe and how the body absorbs and clears it in healthy adults.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 104 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT07535099 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Healthy adults who meet strict screening criteria — BMI 18–26 kg/m2, minimum weight thresholds, normal labs and imaging, no significant medical history, and appropriate reproductive status or contraception — are eligible.

Not a fit: People with active medical conditions, abnormal screening tests, significant gastrointestinal dysfunction, recent acute illness, or women of childbearing potential are excluded and unlikely to benefit from participation.

Why it matters

Potential benefit: If ICP-538 is well tolerated with predictable pharmacokinetics, it could advance to patient studies and eventually contribute to a new therapeutic option.

How similar studies have performed: Single- and multiple-ascending-dose Phase 1 trials in healthy volunteers are the standard approach for first-in-human safety and PK/PD profiling, but ICP-538 itself appears to be at an early, unproven stage.

Eligibility criteria

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 30 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 this trial is running

Beijing, Beijing Municipality

• Beijing Gobroad Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Quankun Zhuang

Conditions Health Services Research