A Phase IIa Study Investigating the Tolerance, Efficacy and Safety of HSK3486

Phase 2 Completed 114 enrolled Sichuan Haisco Pharmaceutical Group Co., Ltd

Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase IIa, open-label, propofol-controlled ,dose-escalation, multi-center Study to evaluate the tolerance, efficacy and safety of HSK3486 for induction of general anesthesia in elective surgery patients.This study is consisted of two cohorts, dose-escalation and dose-expansion cohorts. The doses in dose- expansion cohort were selected from dose-escalation results.

Timeline

Start: 2016-12-06
Primary completion: 2018-06-29
Completion: 2018-07-18

Publications

Zhu Q, Luo Z, Wang X, Wang D, Li J, Wei X, Tang J, Yao S, Ouyang W, Zhang W, Zuo Y, Wang X, Liu J. Efficacy and safety of ciprofol versus propofol for the induction of anesthesia in adult patients: a multicenter phase 2a clinical trial. Int J Clin Pharm. 2023 Apr;45(2):473-482. doi: 10.1007/s11096-022-01529-x. Epub 2023 Jan 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cipepofol	Small molecule	0.1 mg/kg	Intravenous
Subject	Cipepofol	Small molecule	0.2 mg/kg	Intravenous
Subject	Cipepofol	Small molecule	0.3 mg/kg	Intravenous
Subject	Cipepofol	Small molecule	0.4 mg/kg	Intravenous
Subject	Cipepofol	Small molecule	0.5 mg/kg	Intravenous
Subject	Cipepofol	Small molecule	0.6 mg/kg	Intravenous
Subject	Cipepofol	Small molecule	0.7 mg/kg	Intravenous
Subject	Cipepofol	Small molecule	0.8 mg/kg	Intravenous
Comparator	Propofol	Small molecule	2 mg/kg	Intravenous
Comparator	Propofol	Small molecule	2.5 mg/kg	Intravenous

Indications

No indication recorded.