The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-9813 in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Safety: incidence of adverse event (AE), serious adverse event (SAE)
Time frame: 7 days (SAD), 14 days (MAD)
PK parameter of HRS-9813: Area under the concentration time curve (AUC)
Time frame: Days 1-9
PK parameter of HRS-9813: Maximum Plasma Concentration (Cmax)
Time frame: Days 1-9
PK parameter of HRS-9813: Time to maximum plasma concentration (Tmax)
Time frame: Days 1-9
PK parameter of HRS-9813: Half-life (t1/2)
Time frame: Days 1-9
PK parameter of HRS-9813: Apparent clearance (CL/F)
Time frame: Days 1-9
PK parameter of HRS-9813: Apparent volume of distribution (Vz/F)
Time frame: Days 1-9
PK parameter of HRS-9813: Accumulation ratio (Racc)
Time frame: Days 1-9
PK parameter of HRS-9813: Cumulative amount excreted (Ae) in the urine
Time frame: Days 1-2
PK parameter of HRS-9813: Fractional excretion (fe) in the urine
Time frame: Days 1-2
PK parameter of HRS-9813: Renal clearance (CLR)
Time frame: Days 1-2
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