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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: General Anesthetic
• Intervention / Treatment: Drug: HSK3486; Drug: propofol

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

- 1. Subjects undergoing elective surgery requiring endotracheal intubation. 2. Males or females, aged ≥3 and <18 years old, with ASA-PS I to IV. 3. For all females of childbearing potential, negative pregnancy test at screening and baseline. Additionally, females of childbearing potential must agree to use birth control (such as condom, intrauterine device [IUD], abstinence) from the time of consent until 30 days post study drug administration.

4. Subjects must be able to adhere to the study visit schedule and complete all study assessments.

Exclusion Criteria:

• 1. Subjects whose surgery is emergent, or who need emergency treatment during the surgery, or who need transfusion based on the investigator's judgment.

  2. Contraindications to deep sedation/GA or a history of adverse reaction to sedation/GA.

  3. Subjects known to be allergic to excipients in propofol injection, excipients in cipepofol injectable emulsion (soybean oil, glycerol, triglyceride, egg lecithin, sodium oleate and sodium hydroxide), benzodiazepines, opioids, rocuronium, atropine, and their active ingredients; and to have contraindications to propofol.

  4. Subjects with history or evidence of any of sever system diseases increasing the risk of sedation/anesthesia prior to screening/baseline and deemed unsuitable for participation by the investigator: 5. Subjects with respiratory tract management risks prior to/at screening. 6. Subjects who have participated in clinical studies of any drug within 1 month prior to screening.

  7. Females of childbearing potential (i.e., post-menarche) who are unwilling to use contraception during the entire study period.

  8. Subjects unsuitable for this study for any reason as judged by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HSK3486; HSK3486 for induction of general anesthesia.	Drug: HSK3486; HSK3486 for induction of general anesthesia.
Active Comparator: Propofol; Propofol for induction of general anesthesia.	Drug: propofol; Propofol for induction of general anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate of GA induction	A successful GA induction will meet both of the following conditions: Induction success (MOAA/S ≤1) after administration of the study drug, and; One or less top-up doses required without using any rescue drugs.	From start of drug administration to MOAA/S ≤1 (up to 5 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of subjects (6-17 years old) with any injection-site pain (mild, moderate, severe) at time of drug administration on the NRS ≥1.	Injection-site pain is evaluated verbally during study drug administration using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worse imaginable pain).	Up to 8 hours
The proportion of subjects (3-5 years old) with any injection-site pain (mild, moderate, severe) at time of drug administration on the FPS-R ≥2.	Injection-site pain is evaluated during study drug administration using the Faces Pain Scale-Revised (FPS-R), a scale which uses a series of faces ranging from happy (no pain, 0) t(o sad (worst pain, 10) evaluate pain in subjects 3-5 years old.	Up to 8 hours

Collaborators and Investigators

• Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 29, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Phenols; Benzene Derivatives; Propofol; HSK3486
• Other Study ID Numbers: HSK3486-401

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No