Pharmacokinetics, Safety and Efficacy of HR020602 Injection in Children Undergoing General Anesthesia

Summary

This study is divided into two stages: the first stage is a dose verification trial, with a multicenter, open, single arm trial design, which is planned to enroll 10 children with general anesthesia surgery (all using HR020602 injection); If the result shows that the dose is low, 10 children under general anesthesia will be included again for higher dose verification.The second stage is designed as a multicenter, randomized, double-blind, parallel control trial with positive drugs, which is planned to include 25 children with general anesthesia surgery in the test group and 25 children in the control group. There should be at least 20 patients in each of \[2,12\] and \[12,18）age groups.

Timeline

Start

2021-06-07

Primary completion

2023-08-15

Completion

2023-08-15

Publications

• Zou N, Wang X, Wang F, Zou X, Wang SY, Shangguan W, Lin X, Lei Q, Yu Y, Wang Z, Tang L, Ding Y, Zhang J. Efficacy and safety of HR020602 in combination with propofol in children receiving general anesthesia: a multicenter, phase 2 study. BMC Pediatr. 2026 Jan 16;26(1):164. doi: 10.1186/s12887-025-06495-7.

Drugs

Indications

No indication recorded.