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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
104
ICP-538 will be administered as tablet
Matching placebo will be administered as tablet
Beijing Gobroad Hospital
Beijing, Beijing Municipality, China
RECRUITINGTreatment-emergent adverse events (TEAEs)
Incidence and severity of treatment-emergent adverse events (TEAEs).
Time frame: 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.).
Time frame: 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.
Time frame: up to 7 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.