The trial used single-center, randomized, double-blind, placebo-controlled, single-dose ascending study. The trial planned to enroll fifty-six healthy volunteers. The subjects were allocated to eight dose groups, including 0.5 mg (3+1), 1 mg (3+1), 2.5 mg (6+2), 5 mg (6+2), 10 mg (6+2), 20 mg (6+2), 35 mg(6+2) and 50 mg (6+2). Each dose group was allocated test drugs and placebos according to the proportion of subjects in the brackets mentioned above.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
56
Adverse Events (AEs)
Number of participants that experience Adverse Events (AEs)
Time frame: From Screening period to 12 Days Post dose
Serious Adverse Events (SAEs)
Number of participants that experience Serious Adverse Events (SAEs)
Time frame: From Screening period to 12 Days Post dose
clinically significant laboratory assessment abnormalities
Number of participants with clinically significant laboratory assessment abnormalities
Time frame: Up to 72 hours Post dose
clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Time frame: Up to 72 hours Post dose
clinically significant physical examination abnormalities
Number of participants with clinically significant physical examination abnormalities
Time frame: Up to 72 hours Post dose
Area Under the concentration-time curve from time zero to time of the Last Measurable Concentration (AUC0-tlast)
PK Assessment - Area Under the concentration-time curve from time zero to time of the Last Measurable Concentration (AUC0-tlast)
Time frame: Up to 72 hours Post dose
Area under the concentration-time curve from time 0 to infinity (AUCinf)
PK Assessment - Area under the concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Up to 72 hours Post dose
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Maximum observed concentration (Cmax)
PK Assessment - Maximum observed concentration (Cmax)
Time frame: Up to 72 hours Post dose
Time to reach maximum observed concentration (Tmax)
PK Assessment - Time to reach maximum observed concentration (Tmax)
Time frame: Up to 72 hours Post dose
Terminal elimination half-life (t1/2)
PK Assessment - Terminal elimination half-life (t1/2)
Time frame: Up to 72 hours Post dose
Apparent total body clearance (CL/F)
PK Assessment - Apparent total body clearance (CL/F)
Time frame: Up to 72 hours Post dose
Apparent volume of distribution (Vz/F)
PK Assessment - Apparent volume of distribution (Vz/F)
Time frame: Up to 72 hours Post dose
Amount of SYHA136 excreted in urine (Aeu)
PK Assessment - Amount of SYHA136 excreted in urine (Aeu)
Time frame: Up to 72 hours Post dose
Renal clearance (CLr)
PK Assessment - Renal clearance (CLr)
Time frame: Up to 72 hours Post dose
Activated Partial Thromboplastin Time(aPTT)
PD Assessment-Activated Partial Thromboplastin Time(aPTT)
Time frame: Up to 48 hours Post dose
Fibrinogen(Fbg)
PD Assessment-Fibrinogen(Fbg)
Time frame: Up to 48 hours Post dose
Thrombin Time(TT)
PD Assessment-Thrombin Time(TT)
Time frame: Up to 48 hours Post dose
International Normalized Ratio(INR)
PD Assessment-International Normalized Ratio(INR)
Time frame: Up to 48 hours Post dose
Anti-coagulation Factor Xa assays(AXA)
PD Assessment-Anti-coagulation Factor Xa assays(AXA)
Time frame: Up to 48 hours Post dose