The trial is the first human trial. The safety, tolerability, PK and PD of HRS-5965 tablets will be evaluated in healthy subjects and subjects with impaired renal function. The study was divided into three parts: Part 1: single ascending dose, randomized, double-blind study,with 6 dose groups preset, of which 1 group will be administered under fasted and fed conditions; Part 2: Multiple ascending dose, randomized, double-blind study,with 4 dose groups preset; Part 3: an open-label, nonrandomized, single-dose study to evaluate the effect of severe renal impairment (RI) on the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS -5965 compared to demographically-matched healthy participants with normal renal function.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
83
Subjects took HRS5965 tablets in Part 1, Part 2 and Part 3.
Subjects took Placebo in Part 1 and Part 2.
The Affiliated hospital of QingDao University
Qingdao, Shandong, China
The incidence and severity of adverse events to assess safety and tolerability
Time frame: up to 24 days
Area under the plasma concentration versus time curve (AUC) on Day 1 for Part 1 and Part 3
Time frame: Pre-dose to 144 hours post-dose
Peak plasma concentration (Cmax) on Day 1 for Part 1 and Part 3
Time frame: Pre-dose to 144 hours post-dose
Time to maximum plasma concentration (Tmax) on Day 1 for Part 1 and Part 3
Time frame: Pre-dose to 144 hours post-dose
• Area under the plasma concentration versus time curve (AUC) on Day 1 and Day 10 for Part 2
Time frame: Pre-dose to 144 hours post-dose
Peak plasma concentration (Cmax) on Day 1 and Day 10 for Part 2
Time frame: Pre-dose to 144 hours post-dose
Time to maximum plasma concentration (Tmax) on Day 1 and Day 10 for Part 2
Time frame: Pre-dose to 144 hours post-dose
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