This is a single-center, randomized, double-blind, placebo-controlled, SAD study to evaluate the safety, tolerability and PK of HSK47388 in healthy adult participants and preliminarily evaluate the PD of HSK47388
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
CMAX Clinical Research
Adelaide, Australia
Number of participants with treatment-related adverse events as assessed by CTCAE
The incidence, severity, and relationship to IP of AEs. Change from Baseline in clinical laboratory parameters (ie, hematology, serum chemistry, coagulation, and urinalysis parameters), physical examination findings, vital signs
Time frame: 7 days after single dose
Cmax
Maximum concentration
Time frame: Predose up to Day 5 postdose
Tmax
Time to maximum concentration
Time frame: Predose up to Day 5 postdose
AUC
Area under the drug concentrationtime curve
Time frame: Predose up to Day 5 postdose
t1/2
Apparent terminal half-life
Time frame: Predose up to Day 5 postdose
CL/F
Apparent total plasma clearance of drug
Time frame: Predose up to Day 5 postdose
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