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Phase 1 N=48 Randomized Quadruple-blind Treatment

Effects of HSK3486 on Cardiac Repolarization in Health Subjects (TQT)

Anesthesia; Adverse Effect · Cardiac Arrhythmia

Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Change-from-baseline in QTc Interval — 2.1; 5.1; -0.1; 4.1 ms — p=<0.05

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
HSK3486 (Drug); Moxifloxacin Hydrochloride (Drug); Placebo (Drug)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Haisco-USA Pharmaceuticals, Inc.
Primary completion
May 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Change-from-baseline in QTc Interval
2.1; 5.1; -0.1; 4.1; -4.4; 0.0 <0.05 sig

Summary

To assess the effects of a single IV bolus of HSK3486 single dose on cardiac repolarization (QTc interval of the electrocardiogram, and to evaluate the safety and tolerability of a single IV bolus of HSK3486 in healthy subjects

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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.
  • History of allergy to egg or egg products, soybean or soy products.
  • 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.
  • Clinically significant infection/injury/disease within 1 month prior to dosing.
  • Current or recent ( 1.2 × upper limit of normal (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).
  • 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, heart rate (HR) 100 beats/min (test can be repeated once according to investigator's judgment).
  • Oxygen saturation (SpO2) below 95% at baseline.
  • Abnormal 12-lead ECG at screening or baseline (any test abnormality), including any of the following:
  • QTcF > 450 ms
  • QRS > 110 ms
  • PR > 200 ms
  • Second or third-degree AV block
  • Any rhythm other than sinus rhythm of clinical significance.
  • Estimated Glomerular Filtration Rate (eGFR) < 90 mL/min (estimated using MDRD equation).
  • 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.
  • 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 the investigational site.
  • Sperm and egg donation program from screening period to 90 days after study end.
  • Pregnant or lactating women or those with positive pregnancy test results. Male or female subjects of childbearing potential did 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).
  • 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.
  • Use or intend to use of any prescription, nonprescription, vitamin, herbal, or nutraceutical within 14 days prior to dosing or during the clinical trial.
  • Smoking (≥ 5 cigarettes per day) within 6 months prior to screening, or inability to quit smoking during the trial.
  • 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 b
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06795204). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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