The purpose of this study is to evaluate the safety,tolerability,and pharmacokinetics of multiple-accending dose of JS1-1-01。
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
48
Shanghai Mental Health Center
Shanghai, China
Safety and Tolerability
To evaluate the safety and tolerability of JS1-1-01 in healthy participants by assessing the number, severity and type of adverse events, including changes in laboratory safety tests and electrocardiogram (ECG)
Time frame: day 11
Pharmacokinetics profile after a single dose
Cmax of JS1-1-01 and its major metabolites after a single dose.
Time frame: day 1
Pharmacokinetics profile after a single dose
Tmax of JS1-1-01 and its major metabolites after a single dose.
Time frame: day 1
Pharmacokinetics profile after a single dose
t1/2 of JS1-1-01 and its major metabolites after a single dose.
Time frame: day 1
Pharmacokinetics profile after a single dose
AUC0-t of JS1-1-01 and its major metabolites after a single dose.
Time frame: day 1
Pharmacokinetics profile after a single dose
AUC0-∞ of JS1-1-01 and its major metabolites after a single dose.
Time frame: day 1
Pharmacokinetics profile after a single dose
λz of JS1-1-01 and its major metabolites after a single dose.
Time frame: day 1
Pharmacokinetics profile after a single dose
Vd/F of JS1-1-01 and its major metabolites after a single dose.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: day 1
Pharmacokinetics profile after a single dose
CL/F of JS1-1-01 and its major metabolites after a single dose.
Time frame: day 1
Pharmacokinetics profile after multiple dosing.
Css\_min of JS1-1-01 and its major metabolites after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
Css\_max of JS1-1-01 and its major metabolites after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
Css\_av of JS1-1-01 and its major metabolites after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
AUC0-tau of JS1-1-01 and its major metabolites after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
AUC0-∞,ss of JS1-1-01 and its major metabolites after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
AUC0-t,ss of JS1-1-01 and its major metabolites after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
Tmax,ss of JS1-1-01 and its major metabolites after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
T1/2,ss of JS1-1-01 and its major metabolites after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
CLss/F of JS1-1-01 and its major metabolites after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
DF of JS1-1-01 and its major metabolites after multiple dosing.
Time frame: day 11
Pharmacokinetics profile after multiple dosing.
Rac of JS1-1-01 and its major metabolites after multiple dosing.
Time frame: day 11