Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy Subjects

NCT07535099 | Recruiting Phase 1

• 1 other identifier: ICP-CL-01701
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (4)

Single ascending doses of ICP-538 tablet

EXPERIMENTAL

Drug: ICP-538 Tablets

Multiple ascending doses of ICP-538 tablet

EXPERIMENTAL

Drug: ICP-538 Tablets

Single ascending doses of placebo

PLACEBO COMPARATOR

Drug: ICP-538 placebo Tablets

Multiple ascending doses of placebo

PLACEBO COMPARATOR

Drug: ICP-538 placebo Tablets

Interventions

ICP-538 Tablets DRUG

ICP-538 will be administered as tablet

Multiple ascending doses of ICP-538 tablet; Single ascending doses of ICP-538 tablet

ICP-538 placebo Tablets DRUG

Matching placebo will be administered as tablet

Multiple ascending doses of placebo; Single ascending doses of placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Voluntarily sign the ICF..
• BMI between 18-26 kg/m² (inclusive). Male weight ≥50 kg; female weight ≥45 kg.
• 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.
• Laboratory test results at screening and baseline are within the normal reference range.
• 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.

You may not qualify if:

• Evidence or history of clinically significant diseases, or Evidence or history of allergic diseases .
• Clinically significant gastrointestinal dysfunction that may affect drug intake, transport, or absorption.
• Acute illness within 14 days before dosing.
• Severe infection within 6 months before dosing, or chronic/recurrent infections.
• Participant and/or first-degree relative with hereditary immunodeficiency.
• Major trauma or surgery within 3 months before dosing.
• History of active/latent TB or contact with an open TB case within 6 months before dosing.
• Positive urine drug screen.
• Alcohol abuse.
• Use of tobacco/nicotine products within 3 months before the first dose.
• 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.
• Consumption of caffeine-containing foods/beverages within 48 hours before the first dose.
• Use of known CYP3A4 inducers/inhibitors within 30 days or 5 half-lives (whichever is longer) before the first dose.
• Dieting, dietary therapy within 30 days before the first dose.
• Positive for syphilis antibody, HCV-Ab, HBsAg, HBcAb, or HIV-Ab at screening.

Sponsors & Collaborators

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

Study Sites (1)

Beijing Gobroad Hospital

Beijing, Beijing Municipality, 102200, China

RECRUITING

Central Study Contacts

Quankun Zhuang

CONTACT

+86-13011825339; zhuangqk@gobroadhealthcare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2026
• First Posted: April 16, 2026
• Study Start: March 13, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 16, 2026

Record last verified: 2026-03

Locations

CN (1)