This is a randomized, double-blind, placebo-controlled phase I clinical study. The primary objective is to evaluate the safety, tolerability, PK, and PD of single- and multiple-dose HRS-5346 in healthy subjects, and to evaluate the food effects on PK of HRS-5346.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
71
Part 1: single dose. Part 2: single dose with food effects. Part 3: single dose multiple doses.
Part 1: single dose. Part 2: single dose with food effects. Part 3: single dose multiple doses.
The First Affiliated Hospital of Suzhou University
Suzhou, Jiangsu, China
Assess the incidence and severity of adverse events in healthy subjects after single and multiple doses of HRS-5346 tablets
Time frame: About three months from the first medication to the evaluation
Evaluation of AUC0-t of HRS-5346 in plasma and urine
Time frame: About three months after the first dose
Evaluation of AUC0-inf of HRS-5346 in plasma
Time frame: About three months after the first dose
Evaluation of Tmax of HRS-5346 in plasma
Time frame: About three months after the first dose
Evaluation of Cmax of HRS-5346 in plasma
Time frame: About three months after the first dose
Evaluation of t1/2 of HRS-5346 in plasma
Time frame: About three months after the first dose
Evaluation of CL/F of HRS-5346 in plasma
Time frame: About three months after the first dose
Evaluation of Vz/F of HRS-5346 in plasma
Time frame: About three months after the first dose
Evaluation of Ae of HRS-5346 in urine
Time frame: About three months after the first dose
Evaluation of fe of HRS-5346 in urine
Time frame: About three months after the first dose
Evaluation of CLR of HRS-5346 in urine
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Time frame: About three months after the first dose