A Trial Evaluating the Efficacy and Safety of HSK3486 Injectable Emulsion in Subjects Undergoing Fiberoptic Bronchoscopy

Phase 3 Completed 267 enrolled Sichuan Haisco Pharmaceutical Group Co., Ltd

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a Multi-Center, Randomized, Double-Blind, Propofol-Controlled Phase III Clinical Trial. Around 260 eligible subjects are planned to be enrolled and randomized in a 1:1 ratio to either the HSK3486 arm or propofol arm. The main objective is to evaluate the efficacy of HSK3486 vs. propofol for the induction of sedation/anesthesia in subjects undergoing fiberoptic bronchoscopy.

Timeline

Start: 2019-12-06
Primary completion: 2020-06-19
Completion: 2020-07-27

Outcome

Met primary endpoint

paper a 95% confidence interval of - 2.8 to 2.8% for the difference between the groups, which met the predesigned criteria of > - 8% PMID 35157236 ↗

Publications

Luo Z, Tu H, Zhang X, Wang X, Ouyang W, Wei X, Zou X, Zhu Z, Li Y, Shangguan W, Wu H, Wang Y, Guo Q. Efficacy and Safety of HSK3486 for Anesthesia/Sedation in Patients Undergoing Fiberoptic Bronchoscopy: A Multicenter, Double-Blind, Propofol-Controlled, Randomized, Phase 3 Study. CNS Drugs. 2022 Mar;36(3):301-313. doi: 10.1007/s40263-021-00890-1. Epub 2022 Feb 14.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cipepofol	Small molecule	0.4 mg/kg	—
Comparator	Propofol	Small molecule	2 mg/kg	—

Indications

No indication recorded.