This is an open-label, non-randomized, parallel cohorts design, multicenter, single dose phase I study. The primary objectives are: To evaluate the pharmacokinetics (plasma and urine) profile of HRS-9231 following single intravenous injection (0.05 mmol/kg body weight) in patients with mild to severe renal impairment and in healthy volunteers with normal renal function used as reference. To assess dialysability of HRS-923 following a single intravenous injection (0.05 mmol/kg body weight) in patients with end stage renal disease requiring hemodialysis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
41
HRS-9231
Shandong First Medical University First Affiliated Hospital (Shandong Qianfoshan Hospital)
Jinan, Shandong, China
Cmax
Observed maximum plasma concentration. Blood samples will be collected.
Time frame: Prior to HRS-9231 administration and Day 5 (for all cohorts) or Day 6 (only for cohort D).
AUC0-t
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration. Blood samples will be collected.
Time frame: Prior to HRS-9231 administration and Day 5 (for all cohorts) or Day 6 (only for cohort D).
AUC0-∞
Area under the plasma concentration-time curve from time 0 to infinity. Blood samples will be collected.
Time frame: Prior to HRS-9231 administration and Day 5 (for all cohorts) or Day 6 (only for cohort D).
Tmax
Observed time to reach C(max). Blood samples will be collected.
Time frame: Prior to HRS-9231 administration and Day 5 (for all cohorts) or Day 6 (only for cohort D).
Ae
Amount excreted. Urine samples will be collected.
Time frame: Prior to HRS-9231 administration and Day 5 (for all cohorts) or within 6 days (only for cohort D) after administration.
Incidence of treatment emergent AEs (TEAEs)
Time frame: From screening visit to 6 months after administration.
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