Actively Recruiting

Phase 1
Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT07535099

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

Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2026-04-16

104

Participants Needed

1

Research Sites

24 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntarily sign the informed consent form.
  • Body mass index (BMI) between 18-26 kg/m².
  • Male weight at least 50 kg; female weight at least 45 kg.
  • Vital signs, physical exam, ECG, chest X-ray, and abdominal ultrasound within normal range or minor clinically insignificant deviations.
  • Laboratory test results within normal reference ranges.
  • Females must be of non-childbearing potential.
  • Male participants and their partners must agree to use effective contraception during the study and for 3 months after last dose.
  • Male participants must not donate sperm during the contraceptive period.
Not Eligible

You will not qualify if you...

  • History or evidence of clinically significant diseases or allergic diseases.
  • Significant gastrointestinal dysfunction affecting drug absorption.
  • Acute illness within 14 days before dosing.
  • Severe infection within 6 months before dosing or chronic/recurrent infections.
  • Participant or first-degree relative with hereditary immunodeficiency.
  • Major trauma or surgery within 3 months before dosing.
  • History of active or latent tuberculosis or contact with open TB case within 6 months before dosing.
  • Positive urine drug screen.
  • History of alcohol abuse.
  • Use of tobacco or nicotine products within 3 months before first dose.
  • Use of any drugs, herbal medicines, supplements within 14 days before first dose, or systemic corticosteroids, immunosuppressants, hormone therapy within 30 days before first dose.
  • Consumption of caffeine-containing foods or beverages within 48 hours before first dose.
  • Use of CYP3A4 inducers/inhibitors within 30 days or 5 half-lives before first dose.
  • Dieting or dietary therapy within 30 days before first dose.
  • Positive for syphilis antibody, HCV-Ab, HBsAg, HBcAb, or HIV-Ab at screening.
  • Administration of live vaccines within 6 weeks before first dose, planned during study, or within 8 weeks after study.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Gobroad Hospital

Beijing, Beijing Municipality, China, 102200

Actively Recruiting

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Research Team

Q

Quankun Zhuang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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