This is a randomized, double-blinded, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single ascending dose (Part A) and multiple ascending dose (Part B) of HRS5685 tablet in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Enrollment
64
Drug1: HRS5685 Single dose in group A-F and multiple doses in group G-H Drug2: Placebo Single dose in group A-F and multiple doses in group G-H
Safety and tolerability: Incidence and severity of adverse events
Time frame: Up to Day 63 after the last dose
Area under the concentration-time curve during a dosing interval (AUCtau),
Time frame: Pre-dose up to Day 63 after the last dose
Area under the concentration-time curve from time zero to the last quantifiable time point t (AUC0-t)
Time frame: Pre-dose up to Day 63 after the last dose
Area under the concentration-time curve extrapolated to infinity (AUC0-inf )
Time frame: Pre-dose up to Day 63 after the last dose
Maximum observed concentration (Cmax)
Time frame: Pre-dose up to Day 63 after the last dose
Time to Maximum observed concentration (Tmax)
Time frame: Pre-dose up to Day 63 after the last dose
Half-life (t1/2),
Time frame: Pre-dose up to Day 63 after the last dose
Apparent clearance (CL/F)
Time frame: Pre-dose up to Day 63 after the last dose
Apparent volume of distribution (Vz/F)
Time frame: Pre-dose up to Day 63 after the last dose
Trough concentration (Ctrough)
Time frame: Pre-dose up to Day 63 after the last dose
Accumulation ratio (Rac),
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Time frame: Pre-dose up to Day 63 after the last dose
Renal clearance (CLr)
Time frame: Pre-dose up to 72 hours post-dose
Cumulative amount of drug excreted (Ae)
Time frame: Pre-dose up to 72 hours post-dose
Cumulative percentage of dose recovered (fe)
Time frame: Pre-dose up to 72 hours post-dose