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

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

Study Overview

• Status: Recruiting
• Conditions: Health Services Research
• Intervention / Treatment: Drug: ICP-538 Tablets; Drug: ICP-538 placebo Tablets

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Quankun Zhuang; Phone Number: +86-13011825339; Email: zhuangqk@gobroadhealthcare.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 102200
      • Recruiting
      • Beijing GoBroad Hospital
      • Contact: Xiaohua Tian

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single ascending doses of ICP-538 tablet	Drug: ICP-538 Tablets; ICP-538 will be administered as tablet
Experimental: Multiple ascending doses of ICP-538 tablet	Drug: ICP-538 Tablets; ICP-538 will be administered as tablet
Placebo Comparator: Single ascending doses of placebo	Drug: ICP-538 placebo Tablets; Matching placebo will be administered as tablet
Placebo Comparator: Multiple ascending doses of placebo	Drug: ICP-538 placebo Tablets; Matching placebo will be administered as tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment-emergent adverse events (TEAEs)	Incidence and severity of treatment-emergent adverse events (TEAEs).	Up to 7 weeks
The incidence and severity of abnormal clinical laboratory tests	Incidence and severity of clinically significant laboratory test abnormalities during treatment (including hematology, biochemistry, urinalysis, stool routine, etc.).	Up to 7 weeks
The incidence of abnormalities in vital signs, physical examination, 12-lead ECG, etc.	The incidence of abnormalities in vital signs, physical examination, 12-lead ECG, etc.	up to 7 weeks

Collaborators and Investigators

• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 29, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 16, 2026

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: ICP-CL-01701

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No