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

NCT05486416 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: HSK3486-309
• Study Type: interventional
• Target: 465
• Locations: 3 countries
• Sites: 28

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

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

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

Study Arms (2)

HSK3486 for general anesthesia induction

EXPERIMENTAL

HSK3486 for induction of general anesthesia

Drug: HSK3486

Propofol for general anesthesia induction

ACTIVE COMPARATOR

Propofol for induction of general anesthesia

Drug: Propofol

Interventions

HSK3486 DRUG

HSK3486 for induction of general anesthesia

HSK3486 for general anesthesia induction

Propofol DRUG

Propofol for induction of general anesthesia

Also known as: Diprivan

Propofol for general anesthesia induction

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 must satisfy all of the following criteria at the screening visit:
• 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.
• 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 within the screening period and negative urine pregnancy test at baseline (Day 1). Additionally, women of childbearing potential\* and male subjects with female partners of childbearing potential must agree to use contraception as defined in 7.3.4 from the time of consent until 30 days post study drug administration.
• For subjects with known hypothyroidism and/or on thyroid-hormone replacement treatment (i.e., thyroxine), or subjects suspected to have thyroid dysfunction based on clinical laboratory and physical exam, a TSH must drawn and be within normal levels.
• Capable of understanding the procedures and methods of this study, willing to sign an Informed Consent Form (ICF), 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) per investigator judgement, and no hospitalizations and urgent care due to the underlying psychiatric pathology for at least 12 months.
• Women are considered of childbearing potential until becoming post-menopausal, unless she had a documented hysterectomy or bilateral oophorectomy / salpingo-oophorectomy. A woman is considered to be post-menopausal if she had no menses for at least 12 consecutive months (without an alternative medical cause).

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; subjects having contraindications to propofol, opioids, and their antidotes. In cases where the only previous reaction to opioids was itching or nausea, subjects need not be excluded if the investigator believes the subject is not truly allergic to opioids.
• Medical condition or evidence of increased sedation/general anesthesia risk as follows:
• Cardiovascular disorder: 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) ≥450 ms for males and ≥470 ms 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/mental disorders who have not been on a stable treatment regimen (e.g., SSRIs, SNRIs, TCAs, MAOIs, psychotherapy) per investigator judgement, for at least 12 months or who have been hospitalized or had emergent/urgent care due to the underlying psychiatric pathology within the last 12 months.
• 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.
• History of uncontrolled diabetes in the opinion of the investigator.
• History of alcohol abuse within 3 months prior to screening, where alcohol abuse refers to daily alcohol drinking \>2 units of alcohol (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.
• For subjects with known hypothyroidism and/or on thyroid-hormone replacement treatment (i.e., thyroxine), or subjects suspected to have thyroid dysfunction based on clinical laboratory and physical exam who has a TSH value outside the normal range.
• 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 (28)

North Alabama Medical Center

Florence, Alabama, 35630, United States

Location

Helen Keller Hospital

Sheffield, Alabama, 35660, United States

Location

University of Miami Hospital

Miami, Florida, 33136, United States

Location

Gulfcoast Research Institute

Sarasota, Florida, 34232, United States

Location

Phoenix Clinical Research, LLC

Tamarac, Florida, 33321, United States

Location

ForCare Clinical Research

Tampa, Florida, 33613, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

EBGS Clinical Research Center

Snellville, Georgia, 30078, United States

Location

University of Iowa Hospitals and Clinics (Dept of Anesthesia)

Iowa City, Iowa, 52242, United States

Location

U of L Health, University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

The Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Michigan Medicine

Ann Arbor, Michigan, 48109, United States

Location

M3-Emerging Medical Research, LLC

Durham, North Carolina, 27704, United States

Location

Duke University Medical Center (DUMC)

Durham, North Carolina, 27710, United States

Location

The Ohio State University Wexner Medical Center - University Hospital

Columbus, Ohio, 43210, United States

Location

First Surgical Hospital

Bellaire, Texas, 77401, United States

Location

Legent Orthopedic Hospital

Carrollton, Texas, 75006, United States

Location

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Memorial Hermann Village

Houston, Texas, 77043, United States

Location

Clinical Trials of Texas, LLC

San Antonio, Texas, 78229, United States

Location

Endeavor Clinical Trials, LLC

San Antonio, Texas, 78240, United States

Location

Uniwersytecki Szpital Kliniczny W Opolu

Opole, Poland

Location

Państwowy Instytut Medyczny Mswia - Klinika Anestezjologii I Intensywnej Terapii

Warsaw, Poland

Location

Spsk Nr 1 Im. Prof. S. Szyszko

Zabrze, Poland

Location

Hospital Clinic De Barcelona

Barcelona, Spain

Location

Hospital General Universitario De Ciudad Real

Ciudad Real, Spain

Location

Universidad de Navarra - Clinica Universidad de Navarra en Pamplona

Pamplona, Spain

Location

Hospital Clinico Universitario de Valencia (CHUV)

Valencia, Spain

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: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Double blinded, 2:1 ratio of HSK3489 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: August 1, 2022
• First Posted: August 3, 2022
• Study Start: January 12, 2024
• Primary Completion: July 23, 2024
• Study Completion: July 23, 2024
• Last Updated: October 10, 2025
• Results First Posted: August 11, 2025

Record last verified: 2025-09

Locations

PL (3); ES (4); US (21)