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

NCT06795204 | Completed Phase 1 Results FDA Drug

• 1 other identifier: HSK3486-112
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Anesthesia; Adverse Effect; Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Change-from-baseline in QTc Interval

  Corrected for HR using the individual QT correction method (QTcI) - ΔQTcI

  From the base line ECG (D-2) to end of the period, up to 24 hours post-dose

Study Arms (3)

HSK3486( study drug)

EXPERIMENTAL

One time, 0.4 mg/kg, IV bolus administration for 30 (±5) seconds

Drug: HSK3486

Placebo

PLACEBO COMPARATOR

One time, IV bolus administration for 30 (±5) seconds

Drug: Placebo

Moxifloxacin hydrochloride

ACTIVE COMPARATOR

One time, 0.4 g oral administration with 240 mL of warm water on an empty stomach.

Drug: Moxifloxacin Hydrochloride

Interventions

HSK3486 DRUG

Study Drug

Also known as: Cipepofol

HSK3486( study drug)

Moxifloxacin Hydrochloride DRUG

Positive Control

Moxifloxacin hydrochloride

Placebo DRUG

Negative Control

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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%.

You may not qualify if:

• 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 (\< 6 months from screening) hepatobiliary disease.
• Current or history of seizure disorder, including alcohol- or stimulant-related seizure, febrile seizure, or significant family history of idiopathic seizure disorder.
• Family history of sudden death at \<50 years of age.
• History of unexplained loss of consciousness, unexplained syncope, unexplained irregular heartbeats or palpitations, clinically significant head injury.
• 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).
• Positive test results for hepatitis B surface antigen, hepatitis C antibody, treponema pallidum antibody, human immunodeficiency virus (HIV) antigen/antibody combination test.
• Subjects with previous or suspected difficult airway (e.g., modified Mallampati 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.
• Knowledge of any kind of cardiovascular disorder/condition/procedure known to increase the possibility of QT prolongation or history of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, hypomagnesemia, congenital Long QT syndrome, or family history of Long QT Syndrome).
• Laboratory tests at screening or baseline judged clinically significant by the investigator, including, but not limited to, alanine aminotransferase (ALT) or aspartate aminotransferase or aspartate aminotransferase (AST) \> 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) \< 55 beats/min or \> 100 beats/min (test can be repeated once according to investigator's judgment).
• Oxygen saturation (SpO2) below 95% at baseline.

Sponsors & Collaborators

• Haisco-USA Pharmaceuticals, Inc.: lead

Study Sites (1)

Beijing Gobroad Boren Hospital

Beijing, China

Location

Related Publications (1)

• Kleiman R, Rudo T, Daley W, Hu M, Yan P, Zhou R, Hou J. Effects of Cipepofol on Cardiac Depolarization and Repolarization in Healthy Subjects: A Single-Center, Randomized, Placebo and Positive-Controlled Thorough QT Study. Drug Des Devel Ther. 2026 Jan 14;20:565051. doi: 10.2147/DDDT.S565051. eCollection 2026.

  PMID: 41858914 DERIVED

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

HSK3486; Moxifloxacin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Yu-Ling Lai
• Organization: Haisco-USA Pharmaceuticals, Inc.

yuling.lai@haisco-usa.com

856-263-4239

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, blinded (except moxifloxacin hydrochloride tablet), placebo and positive-controlled, 6-sequence, three-period crossover design

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 27, 2025
• Study Start: April 9, 2024
• Primary Completion: May 19, 2024
• Study Completion: November 26, 2024
• Last Updated: January 13, 2026
• Results First Posted: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)