NCT07510945

HSK3486 (Cipepofol) Injectable Emulsion for Induction of General Anesthesia in Pediatric Subjects Undergoing Elective Surgery

A Multicenter, Randomized, Double-blinded, Propofol-controlled, Phase 3b Clinical Study to Evaluate the Efficacy and Safety of HSK3486 (Cipepofol) Injectable Emulsion for Induction of General Anesthesia in Pediatric Subjects Undergoing Elective Surgery

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This multicenter, randomized, double-blinded, propofol-controlled Phase 3b study enrolls pediatric subjects aged 3-17 years undergoing elective surgery with endotracheal intubation. Its primary purpose is to evaluate whether cipepofol is non-inferior to propofol in success of induction of general anesthesia in pediatrics undergoing elective surgery.

Conditions

• General Anesthetic

Interventions

Type	Name	Description
DRUG	HSK3486	HSK3486 for induction of general anesthesia.
DRUG	propofol	Propofol for induction of general anesthesia

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-05-01
• Completion: 2028-05-01
• First posted: 2026-04-06
• Last updated: 2026-04-06

Regulatory

• FDA-regulated drug study