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
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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.
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.
Parallel
ICP-538 Tablets
DrugICP-538 will be administered as tablet
ICP-538 placebo Tablets
DrugMatching placebo will be administered as tablet
Treatment-emergent adverse events (TEAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs).
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.).
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.
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