This is a single-center, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS3797 in Chinese adults. To evaluate the effect of IV infusion duration on the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS3797. To explore the ED95 dosage of HRS3797 in Chinese adults.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Maximum T1 Suppression
Time frame: 0 minute to full neuromuscular recovery after administration
Time to Maximum T1 Suppression
Time frame: 0 minute to full neuromuscular recovery after administration
The onset of neuromuscular block
Time frame: 0 minute to full neuromuscular recovery after administration
The duration of neuromuscular block
Time frame: 0 minute to full neuromuscular recovery after administration
The recovery rate of neuromuscular block
Time frame: 0 minute to full neuromuscular recovery after administration
Pharmacokinetic parameter of HRS3797: Cmax
Time frame: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: AUC0-t
Time frame: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: AUC0-∞
Time frame: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: Tmax
Time frame: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: t1/2z
Time frame: 0 minute to 1.5 hour after administration
Pharmacokinetic parameter of HRS3797: CLz
Time frame: 0 minute to 1.5 hour after administration
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Pharmacokinetic parameter of HRS3797: Vz
Time frame: 0 minute to 1.5 hour after administration
The change of plasma histamine concentration from baseline
Time frame: 0 minute to 1 hour after administration
The incidence and severity of adverse events/serious adverse events
Time frame: from ICF signing date to day 28
The ED95 dosage
Time frame: 0 minute to full neuromuscular recovery after administration