This is a Phase I clinical study to compare the pharmacokinetics (PK) of HRS9531 Injection in participants with mild/moderate hepatic impairment and participants with normal hepatic function, and to evaluate the safety of HRS9531 Injection in these participants.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
HRS9531 injection, specified dose on the specified day.
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITINGMaximum concentration (Cmax)
HRS9531 key PK parameter.
Time frame: Post-dose from Day 1 to Day 29.
The area under the concentration-time curve to the last measurable concentration (AUClast)
HRS9531 key PK parameter.
Time frame: Post-dose from Day 1 to Day 29.
The area under the concentration-time curve extrapolated to infinity (AUCinf)
HRS9531 key PK parameter.
Time frame: Post-dose from Day 1 to Day 29.
Time to maximum concentration (Tmax)
HRS9531 other PK parameter.
Time frame: Post-dose from Day 1 to Day 29.
Half-life (t1/2)
HRS9531 other PK parameter.
Time frame: Post-dose from Day 1 to Day 29.
Apparent clearance (CL/F)
HRS9531 other PK parameter.
Time frame: Post-dose from Day 1 to Day 29.
Apparent volume of distribution (Vz/F)
HRS9531 other PK parameter.
Time frame: Post-dose from Day 1 to Day 29.
Adverse events (AEs)
Safety and tolerability measure.
Time frame: Day 1 to Day 36.
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