The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HRS-3095 oral administration in healthy subjects. This study will also explore food effect and the effect of HRS-3095 on CYP3A4 metabolic enzymes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
66
Oral HRS-3095 tablet.
Oral HRS-3095 placebo tablet.
The Frist Clinical Medicial College of Qingdao University
Qingdao, Shandong, China
RECRUITINGIncidence of adverse events (AEs)
Time frame: Up to 21 days.
Incidence of serious adverse events (SAEs)
Time frame: Up to 21 days.
Maximum concentration (Cmax)
Time frame: Up to 17 days.
Time of maximum concentration (Tmax)
Time frame: Up to 17 days.
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last)
Time frame: Up to 17 days.
Area under the concentration-time curve from time zero to infinity (AUC0-inf)
Time frame: Up to 17 days.
Area under the concentration-time curve from time zero to the end of the dosing interval tau (AUC0-tau)
Time frame: Up to 17 days.
Elimination half-life (t1/2)
Time frame: Up to 17 days.
Apparent clearance (CL/F)
Time frame: Up to 17 days.
Apparent volume of distribution (Vz/F)
Time frame: Up to 17 days.
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