This is a phase I clinical bridging trial, randomized, double-blind, placebo-controlled, single ascending does/ mulelple ascending does study of CS0159 to evaluate the safety, tolerability, pharmacokynetics, pharmacodynamices, and food effect in Chinese healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Shanghai Xuhui Central Hospital
Shanghai, China
Incidence and severity of adverse events [Safety and Tolerability]
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation, and AE of special interest, from baseline up to 15 days.
Time frame: Upto day 15
Dose PK Parameter(C-max)
Evaluate the Peak Plasma Concentration.
Time frame: day 1, day 7
Dose PK Parameter(AUC)
Evaluate the Area under the plasma concentration versus time curve.
Time frame: day 1, day 7
Food effect PK Parameter(C-max)
Evaluate the Peak Plasma Concentration.
Time frame: day 10
Food effect PK Parameter(AUC)
Evaluate the Area under the plasma concentration versus time curve.
Time frame: day 10
QTc analysis
analysize the plasma Concentration relevance to QTcF
Time frame: day 1, day 7
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