Efficacy and Safety of HSK3486 Compared to Propofol for Adults Undergoing Elective Surgery With General Anesthesia

NCT05478174 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: HSK3486-305
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 23

Brief Summary

To demonstrate HSK3486 0.4/0.2 mg/kg (0.4 mg/kg intravenous \[IV\] slow injection over 30 \[±5\] seconds for the first dose, an additional 0.2 mg/kg if needed) is non-inferior to propofol 2.0/1.0 mg/kg (2.0 mg/kg IV slow injection over 30 \[±5\] seconds for first dose, an additional 1.0 mg/kg if needed) in success of induction of general anesthesia in adults undergoing elective surgery.

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

• Success Rate of General Anesthesia Induction

  1. Induction success (MOAA/S ≤1) after administration of the study drug, and 2. One or less top-up doses required without using any rescue drugs.

  From the time of study drug administration to desired depth of anesthesia to MOAA/S≤1 ( up to 5 minutes)

Secondary Outcomes (2)

• Percentage 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

• Percentage of Subjects With Any Injection-site Pain on Numeric Rating Scale ≥1

  From start of drug administration to MOAA/S ≤1 (up to 3 minutes)

Study Arms (2)

HSK3486

EXPERIMENTAL

HSK3486 for general anesthesia induction

Drug: HSK3486

Propofol

ACTIVE COMPARATOR

Propofol for general anesthesia induction

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

You may qualify if:

• \. Subjects undergoing elective surgery (non emergency, non cardiothoracic, and non intracranial surgery, anticipated to last at least 1 hour) requiring endotracheal intubation and inhalation general anesthesia during the maintenance period. Duration of surgery is defined as time from study drug administration to time of transfer from operating room to recovery room or PACU.
• \. Males or females, aged ≥18 years old, with ASA-PS I to IV (Appendix 6). For ASA-PS IV subjects, clinical status must be optimized at time of preoperative anesthesia evaluation per judgement of the anesthesiologist.
• \. BMI ≥18 kg/m2. 4. Vital signs at screening: RR ≥10 and ≤24 breaths/min; SpO2≥92% in ambient air; SBP ≥90 and ≤160 mmHg; DBP ≥55 and ≤100 mmHg; HR ≥55 (or ≥50 if subjects are on beta blockers) and ≤100 beats/min.
• \. For all women of childbearing potential, negative serum pregnancy test at screening and must have negative urine pregnancy test at baseline (Day 1). Additionally, women of childbearing potential\* must agree to use effective contraception as defined in 7.3.4 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 able to complete this study in strict compliance with the study protocol.
• \. Willing to comply with the site's COVID guidelines and testing requirements as applicable.
• \. Patients with psychiatric/mental disorders must be considered stable on treatment (e.g., SSRIs, SNRIs, TCAs, MAOIs, psychotherapy) and no hospitalizations and urgent care for at least 1 year.
• \*Women NOT of childbearing potential are defined as those who have been surgically sterilized (hysterectomy, bilateral salpingo-oophorectomy) or who are postmenopausal (defined 12 months since last regular menses).

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 as follows:
• Cardiovascular disorders: uncontrolled hypertension (SBP\>160 mmHg and/or DBP \>100 mmHg) with or without antihypertensive therapy (antihypertensive therapy should be stable for 1 month prior to screening), serious arrhythmia (including the subjects with implanted pace makers), unstable heart failure, Adams-Stokes syndrome (i.e., syncope or near syncope due to cardiac arrythmia), unstable angina, myocardial infarction occurring within 6 months prior to screening, history of tachycardia/bradycardia requiring medications, third degree atrioventricular block or QT interval corrected for HR using Fridericia's formula (QTcF)≥450ms for males and ≥470ms for females.
• History of severe obstructive lung disease (i.e., forced expiratory volume in 1 second \[FEV1\] \<50% predicted), history of bronchospasm requiring treatment in a hospital emergency room or hospitalization occurring within 3 months prior to screening, developing acute respiratory tract infection within 2 weeks prior to baseline (such as symptoms of fever, shortness of breath, wheezing, nasal congestion, and cough).
• Cerebrovascular disease: subject with a history of serious craniocerebral injury, convulsion, seizure disorder, intracranial hypertension, cerebral aneurysm, or stroke.
• Patients with psychiatric diseases (schizophrenia, mania) who have not been on a stable treatment regimen (with SSRIs, SNRIs, TCAs, MAOIs) for at least 1 year or who have been hospitalized or had emergent/urgent care within the past year.
• Uncontrolled clinically significant conditions of liver (e.g., severe hepatic insufficiency defined as Childs-Pugh class C), kidney, gastrointestinal tract, blood system, nervous system, or metabolic system diseases, judged by the investigator to be unsuitable for involvement in the study.
• Known glycosylated hemoglobin (HbA1c) greater than or equal to 10%.
• Known thyroid-stimulating hormone (TSH) value 10% outside the normal range or on thyroid replacement therapy with a known free T-4 level outside the normal range.
• History of alcohol abuse within 3 months prior to screening, where alcohol abuse refers to daily alcohol drinking \>2 units (1 unit = 360 mL of beer or 45 mL of spirit with a strength of 40% or 150 mL of wine).
• History of drug abuse that, in the opinion of the investigator, may confound the interpretation of safety or efficacy in a study subject.
• Asthma must be stable: stable doses of asthma medications for the past 6 months, no requirement for rescue inhalers or oral steroids within past 6 months, not evaluated in emergency department, urgent care, or hospitalized for an asthma attack within past 1 year.
• History (or family history) of malignant hyperthermia.
• Any previous failure of tracheal intubation.

Sponsors & Collaborators

• Haisco-USA Pharmaceuticals, Inc.: lead

Study Sites (23)

Shoals Medical Trials, Inc.

Sheffield, Alabama, 35660, United States

Location

Arizona Research Center

Phoenix, Arizona, 85053, United States

Location

UC Davis Health

Davis, California, 95616, United States

Location

Coastal Clinical Research Specialists

Jacksonville, Florida, 32250, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Gulfcoast Research Institute, Llc

Sarasota, Florida, 34232, United States

Location

Phoenix Clinical Research

Tamarac, Florida, 33321, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

NextStage Clinical Research - Abay Neuroscience Center

Wichita, Kansas, 67226, United States

Location

Chesapeake Research Group, Llc

Pasadena, Maryland, 21122, United States

Location

Brigham & Women'S Hospital

Boston, Massachusetts, 02115, United States

Location

Duke University Health

Durham, North Carolina, 27710, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Midwest Clinical Research Center

Dayton, Ohio, 45417, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

HD Research

Bellaire, Texas, 77401, United States

Location

Hd Research Llc.

Carrollton, Texas, 75006, United States

Location

The University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Urology San Antonio Research

San Antonio, Texas, 78229, United States

Location

Endeavor Clinical Trials

San Antonio, Texas, 78240, 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
• Organization: Haisco-USA Pharmaceuticals, Inc.

yuling.lai@haisco-usa.com

858-263-4239

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
• Masking Details: double blinded, 2:1 ratio of HSK3486 and Propofol respectively
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Surgical pre-induction analgesia

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 28, 2022
• Study Start: July 26, 2022
• Primary Completion: November 7, 2023
• Study Completion: November 14, 2023
• Last Updated: October 10, 2025
• Results First Posted: October 29, 2024

Record last verified: 2025-09

Locations

US (23)