Efficacy and Safety of HSK3486 Compared to Propofol in Induction of General Anesthesia in Adults Having Elective Surgery

NCT04711837 | Completed Phase 3 Results FDA Drug

• 1 other identifier: HSK3486-304
• Study Type: interventional
• Target: 255
• Locations: 1 country
• Sites: 13

Brief Summary

This is a multicenter, randomized, double-blinded, propofol-controlled, Phase 3 clinical study to evaluate the efficacy and safety of HSK3486 for induction of general anesthesia in adults undergoing elective surgery.

Conditions

Anesthesia

Keywords

Anesthesia; Elective surgery; Propofol

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Successful Anesthesia Induction

  The primary outcome of interest was the success rate of anesthesia induction, defined by the proportion of subjects with successful anesthesia. A subject was considered successful for anesthetic induction if the following conditions were met: induction success Modified Observer's Assessment of Awareness/Sedation Scale (MOAA/S ≤1) after administration of study drug and 1 or less top-up dose required without using any rescue drugs. Where Grade 0 is no response after trapezius squeeze, Grade 1 responds only after painful trapezius squeeze and Grade 5 is completely awake responds to name spoken in normal tone.

  From start of drug administration to MOAA/S ≤1 (up to 5 minutes)

Secondary Outcomes (4)

• Subjects' NRS Pain Score

  Up to 8 hours

• Proportion of Subjects With Successful Induction Who Maintain the Desired Depth of Anesthesia for General Elective Surgery, AND Without Significant Cardiac and Respiratory Depression.

  15 minutes from end of drug administration.

• Proportion of Subjects With Any Injection-site Pain on Numeric Rating Scale.

  From start of drug administration to MOAA/S ≤1 (up to 5 minutes)

• Time to Successful Induction of General Anesthesia.

  From end of drug administration to MOAA/S ≤1 (up to 5 minutes)

Other Outcomes (2)

• Time to the Disappearance of Eyelash Reflex

  From end of drug administration to disappearance of eyelash reflex (up to 5 minutes)

• Number of Participants That Failed to Meet Successful Induction of General Anesthesia

  From start of drug administration to MOAA/S ≤1 (up to 5 minutes)

Study Arms (2)

HSK3486

EXPERIMENTAL

HSK3486 for induction of general anesthesia.

Drug: HSK3486

Propofol

ACTIVE COMPARATOR

Propofol for induction of general anesthesia.

Drug: Propofol

Interventions

HSK3486 DRUG

HSK3486 for induction of general anesthesia.

HSK3486

Propofol DRUG

Propofol for induction of general anesthesia.

Also known as: Diprivan

Propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects undergoing elective surgery (nonemergency, noncardiothoracic, and nonintracranial surgery anticipated to last at least 1 hour ).
• Males or females, aged ≥18 years old, with American Society of Anesthesiologists Physical Status (ASA PS) I to IV.
• Body mass index (BMI) ≥18 kg/m2.
• 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.
• Capable of understanding the procedures and methods of this study, willing to sign an Informed Consent Form, and to complete this study in strict compliance with the study protocol.

You may not qualify if:

• Contraindications to deep sedation/general anesthesia or a history of adverse reaction to sedation/general anesthesia.
• Known to be allergic to eggs, soy products, opioids and their antidotes, or propofol; subject having contraindications to propofol, opioids, and their antidotes.
• Medical condition or evidence of increased sedation/general anesthesia risk.
• Any medication that has the potential to interact synergistically with propofol or HSK3486, including but not limited to all sedatives and hypnotics.
• Laboratory parameters significantly out of range at screening.
• Female subjects with a positive pregnancy test (serum or urine) at screening or baseline; lactating subjects; any subject planning to get pregnant within 1 month after the study (including the male subject's partner).
• Judged by the investigator to have any other factors that make the subject unsuitable for participation in the study.

Sponsors & Collaborators

• Haisco-USA Pharmaceuticals, Inc.: lead

Study Sites (13)

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

Lotus Clinical Research, LLC

Pasadena, California, 91105, United States

Location

Phoenix Clinical Research, LLC

Tamarac, Florida, 33321, United States

Location

The University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

New York City Heath and Hospitals

New York, New York, 10013, United States

Location

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

UNC Health Care System

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27705, United States

Location

The Ohio State University Research Foundation

Columbus, Ohio, 43210, United States

Location

HD Research

Bellaire, Texas, 77401, United States

Location

Plano Surgical Hospital

Plano, Texas, 75093, United States

Location

Endeavor Clinical Trials, LLC

San Antonio, Texas, 78229, United States

Location

JBR Clinical Research

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Interventions

HSK3486; Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Yu-Ling Lai Senior Director Clinical Operations
• Organization: Haisco USA Pharmaceutical Inc.

Yuling.lai@Haisco-usa.com

1 732-26-4759

Study Officials

• William Daley, MD

  Haisco-USA Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 15, 2021
• Study Start: February 11, 2021
• Primary Completion: April 13, 2022
• Study Completion: April 20, 2022
• Last Updated: October 10, 2025
• Results First Posted: May 26, 2023

Record last verified: 2025-09

Locations

US (13)