The trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) ,and pharmacodynamics (PD) characteristics of SK-08 in healthy participants.
The trial is conducted in a single-center, randomized, double-blind, placebo-controlled, dose-increasing design. To evaluate the safety, tolerability, pharmacokinetics(PK) ,and pharmacodynamics (PD) characteristics of SK-08 in healthy participants. Seven dose groups (A1 to A7) were preset. A total of 48 healthy subjects were planned to be enrolled.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
The First Affiliated Hospital,Zhejiang University
Hangzhou, Zhejiang, China
RECRUITINGSafety Evaluation
The occurrence of AE during the experiment
Time frame: up to Day 12
PK Evaluation(Cmax)
Pharmacokinetic characteristics after administration (Cmax)
Time frame: within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour,2.5 hour, 2.75hour,3 hour, 3.5hour,4 hour, 5hour,6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing
PK Evaluation(Tmax)
Pharmacokinetic characteristics after administration
Time frame: within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour,2.5 hour, 2.75hour,3 hour, 3.5hour,4 hour, 5hour,6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing
PK Evaluation( AUC0-T)
Pharmacokinetic characteristics after administration (AUC0-T)
Time frame: within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour,2.5 hour, 2.75hour,3 hour, 3.5hour,4 hour, 5hour,6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing
PK Evaluation ( AUC0-∞)
Pharmacokinetic characteristics after administration ( AUC0-∞)
Time frame: within 1 hour pre-dosing and at 0.5 hour, 1 hour, 1.5 hour, 2 hour, 2.25hour,2.5 hour, 2.75hour,3 hour, 3.5hour,4 hour, 5hour,6 hour, 8 hour, 12 hour, 24 hour , 48 hour, 72 hour and 96hour post-dosing
PD Evaluation(Heart rate)
Heart rate
Time frame: within 1.0hour pre-dosing, and at 1.0hour, 2.0hour, 4.0hour, 6.0h, and 12.0h post dosing
PD Evaluation(blood pressure)
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blood pressure
Time frame: within 1.0hour pre-dosing, and at 1.0hour, 2.0hour, 4.0hour, 6.0h, and 12.0h post dosing
PD Evaluation(changes in cGMP concentration levels)
changes in cGMP concentration levels
Time frame: within 1.00 hour pre-dosing and 0.50 hour, 1hour,1.5hour,2hour,2.5hour,3hour,4hour,5hour,6hour,8hour,12hour post-dosing
QT interval analysis indicators(QTcF)
QTcF
Time frame: With in1hour pre-dosing,and at 0.5hour、1.0hour、1.5hour、2.0hour、4.0hour、6.0hour、12.0hour、24.0hour post-dosing
QT interval analysis indicators(ΔQTcF)
ΔQTcF
Time frame: With in1hour pre-dosing,and at 0.5hour、1.0hour、1.5hour、2.0hour、4.0hour、6.0hour、12.0hour、24.0hour post-dosing