This single-center, randomized, placebo-controlled, double-blind, dose-increasing study was designed to evaluate the safety, tolerability, and pharmacokinetics of multiple successive dosing in healthy Chinese adult subjects.In this study, 20 healthy adult subjects were enrolled in a multi-dose study in the 30mg and 40mg groups.
In this study, subjects were given multiple doses in the corresponding dose group
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
20
AD16 was taken continuously.Firstly, a 30 mg (bid) multiple dose study was conducted, followed by a 40 mg (bid) multiple dose study
AD16 placebo was taken continuously.Firstly, a 30 mg (bid) multiple dose study was conducted, followed by a 40 mg (bid) multiple dose study
The Central South University Xiang Ya Hospital
Changsha, China
Adverse events
The number of adverse events
Time frame: day-7 to day11
Serious adverse events
The number of serious adverse events
Time frame: day-7 to day11
Number of participants with abnormal laboratory test results
Laboratory tests include Blood routine, blood biochemistry, coagulation function and urine routine, etc.
Time frame: Screening period (day-7 to day-2) and day11
Number of participants with abnormal vital signs
Pulse, blood pressure, body temperature and respiratory rate were observed at different time points before and after medication.
Time frame: Screening period(day-7 to day-1)、days1、4、5、6、8、9
Number of participants with abnormal 12-lead electrocardiogram readings
Abnormal12-lead electrocardiogram
Time frame: Screening period(day-7 to day-2)、days1、6、11
Number of participants with abnormal physical examination findings
The skin, mucosa, lymph nodes, head, neck, chest, abdomen, spine/limbs and nervous system were observed at different time points before and after medication.
Time frame: Screening period(day-7 to day-2)、days11
Concomitant medication
Any concomitant medication
Time frame: Up to day 11
Tmax of AD16
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Time to reach the maximum (peak) plasma concentration following drug administration
Time frame: Up to day 11
Cmax of AD16
Maximum (peak) plasma drug concentration
Time frame: Up to day 11
t1/2z of AD16
Elimination half-life (to be used in a one-compartment or noncompartmental model)
Time frame: Up to day 11
AUC 0-∞ of AD16
Area under the plasma concentration-time curve(AUC) from time zero to infinity
Time frame: Up to day 11
AUC 0-t of AD16
Area under the plasma concentration-time curve(AUC) from time zero to time t
Time frame: Up to day 11
Vd/F of AD16
Apparent volume of distribution after non-intravenous administration
Time frame: Up to day 11
CL/F of AD16
CL/F is defined as the ratio of total clearance(CL) to bioavailability(F).
Time frame: Up to day 11
λz of AD16
Terminal disposition rate constant/terminal rate constant
Time frame: Up to day 11
AUC 0-48h of AD16
Area under the plasma concentration-time curve from time zero to time 48h
Time frame: Up to day 11
AUC_%Extrap of AD16
AUC\_%Extrap is residual area percentage
Time frame: Up to day 11
Tmax,ss of AD16
Time to reach the maximum (peak) plasma concentration following drug administration at steady state
Time frame: Up to day 11
Cmax, ss of AD16
Maximum (peak) steady-state plasma drug concentration during a dosage interval
Time frame: Up to day 11
Cavg,ss of AD16
Cavg,ss is the steady-state mean concentration
Time frame: Up to day 11
t1/2,ss of AD16
Elimination half-life(steady state )
Time frame: Up to day 11
AUC 0-τ,ss of AD16
The area under the plasma concentration-time curve during a dosing interval at steady state
Time frame: Up to day 11
AUC 0-48h,ss of AD16
Area under the plasma concentration-time curve from the last dose to 48 h
Time frame: Up to day 11
AUC 0-∞,ss of AD16
The area under the plasma concentration-time curve is extrapolated from the last dose to infinity
Time frame: Up to day 11
CL/F,ss of AD16
CL/F is defined as the ratio of total clearance(CL) to bioavailability(F)(steady state )
Time frame: Up to day 11
Rac of AD16
Rac is accumulation ratio
Time frame: Up to day 11
DF of AD16
Degree of fluctuation(DF)Percentage fluctuation in steady state = 100 × (Cmax,ss -Cmin,ss)/Cavg,ss
Time frame: Up to day 11
Vd/F,ss of AD16
Apparent volume of distribution after non-intravenous administration (steady state )
Time frame: Up to day 11