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RecruitingNCT06379867Updated Apr 26, 2024

A Study to Evaluate the Effects of HSK3486 Administration on Cardiac Repolarization in Healthy Subjects

A Phase 1 interventional study of HSK3486 and Placebo in Anesthesia, sponsored by Haisco Pharmaceutical Group Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-26.

Sponsored by Haisco Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2024, 2 years 4 months ago, but the record still lists the study as recruiting.
  • Started Apr 2024; still recruiting 2 years 6 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

Assess the effects of a single IV bolus of HSK3486 single dose on cardiac repolarization for healthy subjects.

02

Conditions studied

  • Anesthesia
03

In context

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd. is the lead sponsor of 114 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Ability to understand and comply with protocol requirements and is willing voluntarily sign written ICF.
  2. Healthy participants at age from 18 to 45 years old (inclusive) at Screening.
  3. Male body weight ≥50 kg, female body weight ≥45 kg, with a body mass index BMI of 19\~28 kg/m2 (inclusive).
  4. Left Ventricular Ejection Fraction (LVEF)≥50%.

Exclusion criteria

Exclusion Criteria:

  1. Past or present clinically significant systemic disease as judged by the Investigator including, but not limited to psychiatric, neurologic, pulmonary, respiratory, cardiac, gastrointestinal, genitourinary, renal, hepatic, metabolic, endocrinologic, hematological, or autoimmune disorders.
  2. History of allergy to egg or egg products, soybean or soy products.
  3. History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance. History of allergy to HSK3486 or moxifloxacin or its investigational product excipients, or history of specific allergies (asthma, urticaria, eczema, etc.), or history of tendinitis or tendon rupture due to moxifloxacin or any other quinolone drug.
  4. Clinically significant infection/injury/disease within 1 month prior to dosing.
  5. Current or recent (\< 6 months from screening) hepatobiliary disease.
  6. Current or past history of seizure disorder, including alcohol- or stimulant-related seizure, febrile seizure, or significant family history of idiopathic seizure disorder.
  7. Family history of sudden death at \<50 years of age.
  8. History of unexplained loss of consciousness, unexplained syncope, unexplained irregular heartbeats or palpitations, clinically significant head injury.
  9. Pre-existing condition interfering with normal gastrointestinal anatomy or motility, hepatic and/or renal function, or conditions that could interfere with the absorption, metabolism, and/or excretion of study drug (e.g., history of bariatric surgery or intestinal bypass surgery; simple uncomplicated appendectomies and hernia repairs are allowed, but cholecystectomy is not allowed).
  10. Positive test results for hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, human immunodeficiency virus (HIV) antigen/antibody combination test.
  11. Subjects with previous or suspected difficult airway (e.g., modified Mallampti score III-IV, congenital microglossia, mandibular dysplasia), or respiratory insufficiency, history of obstructive pulmonary disease, history of asthma, sleep apnea syndrome; history of failed tracheal intubation; history of bronchospasm requiring treatment within 3 months prior to screening; acute respiratory infection, and with obvious symptoms such as fever, wheezing, nasal congestion or cough within 1 week prior to baseline.
  12. Knowledge of any kind of cardiovascular disorder/condition/procedure known to increase the possibility of QT prolongation or history of risk factors for TdP (e.g., heart failure, hypokalemia, hypomagnesemia, congenital Long QT syndrome, or family history of Long QT Syndrome.
  13. Laboratory tests at screening or baseline judged clinically significant by the investigator, including, but not limited to, ALT or AST > 1.2 ×ULN (the upper limit of the reference range at screening or baseline), direct bilirubin > ULN (congenital nonhemolytic hyperbilirubinemia [e.g., suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable), creatine kinase (CK) > ULN (one repeat test allowed), thyroid stimulating hormone (TSH) outside normal range (0.75 to 5.6 mIU/L) , serum potassium outside normal range (3.5 to 5.3 mmol/L).
  14. Rest sitting vital sign results abnormal and clinically significant at screening or baseline, ear temperature outside normal range, diastolic blood pressure ≥ 90 mmHg or systolic blood pressure ≥ 140 mmHg, HR \< 55 beats/min or > 100 beats/min (test can be repeated once according to investigator's judgment).
  15. Oxygen saturation (SpO2) below 95% at baseline.
  16. Abnormal 12-lead ECG at screening or baseline (any test abnormality), including any of the following:

    1. QTcF > 450 ms
    2. QRS > 110 ms
    3. PR > 200 ms
    4. Second or third-degree AV block
    5. Any rhythm other than sinus rhythm of clinical significance.
  17. Estimated Glomerular Filtration Rate (eGFR) \< 90 mL/min (estimated using MDRD equation).
  18. Participation in another clinical study of an investigational drug (or medical device) within 3 months (or 5 half-lives, whichever is longer) prior to dosing, or previous participation in any other clinical trial related to HSK3486.
  19. Donation of blood within 3 months prior to screening, plasma within 2 weeks prior to screening, platelets within 6 weeks prior to screening, or receive blood products within 2 months prior to admission to a the investigational site.
  20. Sperm and egg donation program from screening period to 90 days after study end.
  21. Pregnant or lactating women or those with positive pregnancy test results. Male or female subjects of childbearing potential do not agree to use an effective method of contraception from the time of signing ICF until 90 days after leaving the investigational site after the last dose (see Appendix 6 for details of specific contraceptive methods).
  22. Use or intend to use any medications/products known to alter drug absorption, metabolism, or elimination processes, including St. John's wort, within 30 days prior to dosing or during the clinical trial.
  23. Use or intend to use of any prescription, nonprescription, vitamin, herbal, or nutraceutical within 14 days prior to dosing or during the clinical trial.
  24. Smoking (≥ 5 cigarettes per day) within 6 months prior to screening, or inability to quit smoking during the trial.
  25. Positive alcohol breath test, or regular drinking within 6 months prior to dosing or during the trial, i.e. drinking more than 21 units (men) or 14 units (women) of alcohol per week (1 unit =360 mL beer or 45 mL spirits or 150 mL wine at 40% alcohol).
  26. Positive urine drug abuse screening (morphine, tetrahydrocannabinol, methamphetamine, methylenedioxyamphetamine, ketamine), or history of drug abuse, drug dependence within 6 months prior to screening, or drug use within 3 months prior to screening.
  27. Subjects who tested positive for COVID-19 during screening.
  28. Eating fruits or foods affecting metabolic enzymes, such as grapefruit (citrus), pomelo, etc., within 7 days prior to screening; and not abstaining from the above beverages, fruits or foods during the study period.
  29. Previous chronic excessive consumption (more than 8 cups per day, 1 cup =250 mL) of tea, coffee or caffeinated beverages, or intake of caffeine and/or purine-rich foods or beverages (e.g. coffee, tea, chocolate, caffeinated carbonated beverages, cola, etc.) within 48 hours prior to screening, or refusal to stop drinking tea, coffee and/or caffeinated beverages during the trial.
  30. Performing or unwilling to refrain from strenuous physical activity, which could cause muscle aches or injury, including contact sports, at any time from 3 days prior to dosing through the end-of-study visit.
  31. Subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical disease (e.g., infectious disease).
  32. Any condition or situation that, in the opinion of the investigator, would prevent proper evaluation of the safety or efficacy of the study drug according to the study protocol (e.g., poorly compliant subject, poorly vascular condition, allergies to medical plastics/latex).
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Experimental
    HSK3486

    Drug: HSK3486

  • Placebo comparator
    Placebo

    Drug: Placebo

  • Active comparator
    Moxifloxacin

    Drug: Moxifloxacin

Interventions

  • DrugHSK3486

    0.4 mg/kg, IV bolus administration

    Also known as: Ciprofol

  • DrugPlacebo

    IV bolus administration

  • DrugMoxifloxacin

    0.4 g, Oral administration with 240 mL

06

What researchers measure

Primary outcomes

  1. ΔQTcI

    The change-from-baseline in QTc interval, corrected for HR using the individual QT correction method (QTcI).

    Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 2 in each period.

Secondary outcomes

  1. ΔHR, ΔQTcF, ΔPR, and ΔQRS

    Change-from-baseline HR, QTcF, PR, and QRS intervals, which will be used as the dependent variable for calculation of model-derived ΔΔHR, ΔΔQTcF, ΔΔPR, and ΔΔQRS for the by-time point analysis, respectively.

    Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 2 in each period.

  2. Categorical outliers for QTcI, QTcF, HR, PR, and QRS intervals

    Categorical outliers for QTcI, QTcF, HR, PR, and QRS intervals.

    Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 2 in each period.

  3. AE and SAE

    Incidence of AE and SAE

    Time frame: Up to Day 18

  4. Cmax

    Maximum Observed Plasma Concentration

    Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 2 in each period

  5. AUClast

    Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration of HSK3486

    Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 2 in each period

  6. t1/2

    Elimination Half-Life

    Time frame: Pre-dose and at multiple timepoints post-dose on Days 1 to 2 in each period

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06379867
Lead sponsor
Haisco Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Apr 23, 2024
Start date
Apr 7, 2024
Primary completion
May 30, 2024 (estimated)
Completion
Aug 30, 2024 (estimated)
Last update
Apr 26, 2024

Study contacts

Chen Meixia
Contact
chenmeixia@haisco.com
67258779 ext. 028

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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