The study is to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profiles of CS12192 after single or multiple oral administration, as well as the food effect on the pharmacokinetics in healthy subjects.
This study consists of 3 parts: single ascending dose (SAD), multiple ascending dose (MAD) and food effect (FE). Both SAD and MAD study are randomized, double-blind, placebo-controlled design. The FE study use a randomized, open-label, two-period, two-crossover design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
Participants receive CS12192 orally single or multiple doses
Participants receive placebo matching CS12192 orally single or multiple doses
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
the Number of Adverse Events (AEs)
To investigate the safety and tolerability by assesment of AEs following administration.
Time frame: up to 14 days
Pharmacokinetic parameters - Area Under the Curve(AUC)
Area Under the Plasma Concentration-time Curve of CS12192.
Time frame: From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses. From time 0 to 48 hours after the last dose for food effect study.
Pharmacokinetic parameters - Peak Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration of CS12192.
Time frame: From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses. From time 0 to 48 hours after the last dose for food effect study.
Pharmacokinetic parameters - Time of peak concentration(Tmax)
Time to reach maximum observed plasma concentration of CS12192.
Time frame: From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses.From time 0 to 48 hours after the last dose for food effect study. From time 0 to 48 hours after the last dose for food effect study.
Pharmacokinetic parameters - Plasma Elimination Half-Life(t1/2)
Plasma Elimination Half-Life of CS12192.
Time frame: From time 0 to 48 hours for single dose. From time 0 to 48 hours after the last dose for multiple doses.From time 0 to 48 hours after the last dose for food effect study. From time 0 to 48 hours after the last dose for food effect study.
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