Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy S… (NCT07535099) | Clinical Trial Compass
RecruitingPhase 1
Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ICP-538 in Healthy Subjects
China104 participantsStarted 2026-03-13
Plain-language 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
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕
What they're measuring
1
Treatment-emergent adverse events (TEAEs)
Timeframe: Up to 7 weeks
2
The incidence and severity of abnormal clinical laboratory tests
Timeframe: Up to 7 weeks
3
The incidence of abnormalities in vital signs, physical examination, 12-lead ECG, etc.