This study aims to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-1301 following single and multiple dose administration in healthy subjects. The study consists of two parts (Part 1 and Part 2) with 82 subjects planned to be enrolled. Possible adjustments to sample size, treatment duration and follow-up time will depend upon emerging data.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
82
HRS-1301.
HRS-1301 placebo.
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Adverse events (AEs)
Time frame: From the first dose up to Day 21.
HRS-1301 plasma drug concentration.
Time frame: Up to 168 hours after the first dosing.
HRS-1301 urine drug concentration.
Time frame: Up to 168 hours after the first dosing.
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