Actively Recruiting
Phase I Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of ICP-538 Tablets in Healthy Adults
Led by Beijing InnoCare Pharma Tech Co., Ltd. · Updated on 2026-04-16
104
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase I randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ICP-538 in healthy adults aged 18 to 50 years. The trial focuses on evaluating how the drug behaves in the body and monitoring any side effects or lab abnormalities over the study period. The study involves administering single and multiple ascending doses of ICP-538 tablets or matching placebo tablets. Participants receive these doses under controlled conditions to understand the effects of different dosing levels. Both experimental and placebo groups are included, with doses increasing to evaluate safety and drug behavior. Participants will undergo regular assessments including vital signs, physical exams, ECGs, lab tests, chest X-rays, and abdominal ultrasounds to monitor their health and detect any adverse events. The primary outcomes include tracking treatment-emergent adverse events, abnormal lab results, and any changes in vital signs or examinations over up to 7 weeks of observation. The total participation duration aligns with these monitoring timelines.
CONDITIONS
Brief Title
Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form
- Body mass index (BMI) between 18 and 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 limits or minor clinically insignificant deviations
- Laboratory test results within normal reference ranges
- Females of non-childbearing potential
- Male participants and their partners agree to use effective contraception during the study and for 3 months after the last dose
- Male participants agree not to donate sperm during the study and for 3 months after the last dose
You will not qualify if you...
- History or evidence of clinically significant diseases or allergic conditions
- Significant gastrointestinal dysfunction affecting drug intake or absorption
- Acute illness within 14 days before dosing
- Severe infection in the past 6 months 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 recent contact with open TB case within 6 months
- Positive urine drug screen
- History of alcohol abuse
- Use of tobacco or nicotine products within 3 months before first dose
- Use of any prescription or non-prescription drugs, herbal medicines, supplements within 14 days before first dose
- Use of systemic corticosteroids, immunosuppressants, or hormone therapy within 30 days before first dose
- Consumption of caffeine-containing foods or beverages within 48 hours before first dose
- Use of known CYP3A4 inducers or inhibitors within 30 days or five half-lives before first dose
- Dieting or dietary therapy within 30 days before first dose
- Positive for syphilis antibody, HCV antibody, hepatitis B surface antigen, hepatitis B core antibody, or HIV antibody at screening
- Receipt of live vaccines within 6 weeks before first dose or planned during study or within 8 weeks after study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 weeks
Participants receive single or multiple ascending doses of ICP-538 or matching placebo tablets.
Multiple visits during dosing period
Trial Site Locations
Total: 1 location
1
Beijing Gobroad Hospital
Beijing, Beijing Municipality, China, 102200
Actively Recruiting
Research Team
Q
Quankun Zhuang
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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