General AnesthesiaPhase 3NCT05478174
Efficacy and Safety of HSK3486 Compared to Propofol for Adults Undergoing Elective Surgery With General Anesthesia
A Phase 3 study testing HSK3486 and Propofol in people with General Anesthesia, run by Haisco-USA Pharmaceuticals, Inc. at 23 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- General Anesthesia
- What is being tested?
- HSK3486 and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 23 sitesUnited States
- Study dates
- 26 Jul 2022to 14 Nov 2023
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. 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.
- 2. 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.
- 3. 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.
- 5. 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.
- 6. 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.
- 7. Willing to comply with the site's COVID guidelines and testing requirements as applicable.
- 8. 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).
Who cannot join
- 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.
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- 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.
- Management risks of respiratory tract and judged by the investigator to be unsuitable for inclusion in the study as follows:
- 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.
- Judged to have a difficult airway for endotracheal intubation in the opinion of the Investigator based on parameters such as modified Mallampati score (Grade III or IV [Appendix 7], neck mobility, short thyromental distance, and/or history of difficult intubation).
- Any medication that has the potential to interact synergistically with propofol or HSK3486, including but not limited to all sedatives and hypnotics (e.g., benzodiazepines and opioids) taken within 5 half-lives prior to Day 1.
- Laboratory parameters measured at screening with the following levels:
- Neutrophil count ≤1.5 x 109/L
- Platelet count <80 x 109/L
- Hemoglobin <90 g/L (without blood transfusion within 14 days)
- Alanine transaminase and/or aspartate transaminase ≥2.0 x upper limit of normal (ULN)
- Total bilirubin ≥2.0 x ULN
- Severe renal impairment defined by creatinine clearance (CrCl) ≤30 mL/min
- Female subjects with a positive pregnancy test at screening (serum) or baseline (urine); 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.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
HD Research
Bellaire, Texas, 77401
Brigham & Women'S Hospital
Boston, Massachusetts, 02115
Hd Research Llc.
Carrollton, Texas, 75006
Rush University Medical Center
Chicago, Illinois, 60612
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
UC Davis Health
Davis, California, 95616
Midwest Clinical Research Center
Dayton, Ohio, 45417
Duke University Health
Durham, North Carolina, 27710
The University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
Coastal Clinical Research Specialists
Jacksonville, Florida, 32250
University of Miami Hospital
Miami, Florida, 33136
Chesapeake Research Group, Llc
Pasadena, Maryland, 21122
Arizona Research Center
Phoenix, Arizona, 85053
Oregon Health & Science University
Portland, Oregon, 97239
Jbr Clinical Research
Salt Lake City, Utah, 84107
Urology San Antonio Research
San Antonio, Texas, 78229
Endeavor Clinical Trials
San Antonio, Texas, 78240
Gulfcoast Research Institute, Llc
Sarasota, Florida, 34232
Shoals Medical Trials, Inc.
Sheffield, Alabama, 35660
Phoenix Clinical Research
Tamarac, Florida, 33321
ForCare Clinical Research
Tampa, Florida, 33613
NextStage Clinical Research - Abay Neuroscience Center
Wichita, Kansas, 67226
About this study
Official title: A Multicenter, Randomized, Double-blinded, Propofol-controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HSK3486 Injectable Emulsion for Induction of General Anesthesia in Adults Undergoing Elective Surgery
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.
Read the detailed description
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 with endotracheal intubation.
After screening, eligible subjects will be randomized in a 2:1 ratio to receive either HSK3486 0.4/0.2 mg/kg (i.e., 0.4 mg/kg IV slow injection over 30 [±5] seconds followed by an additional 0.2 mg/kg dose over 10 [±2] seconds if needed) or propofol 2.0/1.0 mg/kg (i.e., 2.0 mg/kg IV slow injection over 30 [±5] seconds followed by an additional 1.0 mg/kg dose over 10 [±2]seconds if needed) in a blinded manner. Enrolled subjects will be stratified by American Society of Anesthesiologists Physical Status (ASA-PS; I-II and III-IV), age (<65 and ≥65 years), and Body Mass Index (BMI <35 and ≥35 kg/m2). Endotracheal intubation will be performed after adequate anesthetic induction (Modified Observer's Assessment of Awareness/Sedation [MOAA/S] ≤1) (Appendix 1) has been achieved and administration of neuromuscular blocking agent.
Before surgery, premedication is allowed except for sedative-hypnotic or analgesic drugs. Premedication should be recorded if used.
Prior to administration of the study drug in the operating room, the preoperative readiness of each subject will be confirmed. Oxygen will be supplied through a facemask (oxygen flow rate: ≥4 L/min) at least 2 minutes before study drug administration. Subsequently, the investigator can adjust the oxygen flow according to the specific situation of the subject and maintenance IV solution (normal saline [NS], lactated ringer's [LR], or 5% dextrose) will be administrated through IV infusion. Throughout the preinduction and induction periods, a timing device must be used to allow accuracy and sequencing of necessary assessments.
- Conditions
- General Anesthesia
- Being tested
- HSK3486, Propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK3486Drug
HSK3486 for induction of general anesthesia
PropofolDrug
Also called Diprivan
Propofol for induction of general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| HSK3486 | Experimental | HSK3486 for general anesthesia induction Receives: Drug: HSK3486 |
| Propofol | Active comparator | Propofol for general anesthesia induction Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of General Anesthesia Induction
- Induction success (MOAA/S ≤1) after administration of the study drug, and
- One or less top-up doses required without using any rescue drugs.
Measured: 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
The outcome is defined by all the following conditions:
- Desired depth of anesthesia for general elective surgery is defined if all following criteria are met: i) No clinical signs of inadequate depth of anesthesia, such as lacrimation, movement, vomiting, coughing, laryngospasm, bucking, swallowing reflex or bronchospasm etc. ii) No blood pressure (SBP, DBP, or MAP) increases more than 20% from baseline in response to any major operational procedures or noxious stimulus in defined period. iii) Subjects maintain desired depth of anesthesia for general elective surgery with BIS as an objective assessment (after reaching initial lowest value, BIS remains sustainable level at not more than 60).
- No significant respiratory depression, such as apnea, prior to the administration of rocuronium bromide.
- No significant cardiac depression indicated by blood pressure decrease that requires intervention, i.e., vasopressors and/or IV fluid resuscitation.
Measured: 15 minutes from end of drug administration
Percentage of Subjects With Any Injection-site Pain on Numeric Rating Scale ≥1
0 = No Pain 1-3 = Mild Pain 4-6 = Moderate Pain 7-9 = Severe Pain 10 = Worst pain imaginable
Measured: From start of drug administration to MOAA/S ≤1 (up to 3 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2022
- Study start26 Jul 2022
- Primary completion7 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for General AnesthesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Surgical pre-induction analgesia
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco-USA Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05478174
- Sponsor's protocol ID
- HSK3486-305
- Status last verified
- Sep 2025
- First submitted
- 22 Jul 2022
- Last updated
- 10 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No