This is a Phase I Randomized, Double-Blind, Placebo-Controlled, Dose Escalation, Single Center Bridging Study to Evaluate Safety, Tolerability and Pharmacokinetics of ASC42 in Chinese Healthy Subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
30
Xiangya Boai Rehabilitation Hospital
Changsha, Hunan, China
AUC of ASC42
Evaluate the Area under the plasma concentration versus time curve.
Time frame: Up to 4 days
Cmax of ASC42
Evaluate the Peak Plasma Concentration.
Time frame: Up to 4 days
t1/2 of ASC42
Evaluate the Terminal-Phase Half-Life.
Time frame: Up to 4 days
CL/F of ASC42
Evaluate the Apparent Systemic Clearance.
Time frame: Up to 4 days
Vd/F of ASC42
Evaluate the Apparent Volume of Distribution.
Time frame: Up to 4 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 7 days.
Time frame: Up to 7 days
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