Anesthesia; Adverse EffectPhase 1NCT06795204
Effects of HSK3486 on Cardiac Repolarization in Health Subjects (TQT)
A Phase 1 study testing HSK3486 and Moxifloxacin Hydrochloride in people with Anesthesia; Adverse Effect and Cardiac Arrhythmia, run by Haisco-USA Pharmaceuticals, Inc. at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anesthesia; Adverse Effect, Cardiac Arrhythmia
- What is being tested?
- HSK3486 and Moxifloxacin Hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2024to 26 Nov 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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%.
Who cannot join
- 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.
Show all 37Show fewer
- 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.
- 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 beer or 45 mL spirits or 150 mL wine at 40% alcohol).
- 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.
- Subjects who tested positive for COVID-19 during screening.
- 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.
- 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.
- 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.
- Subjects who were compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical disease (e.g., infectious disease).
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Positive and Placebo-Controlled Study to Evaluate the Effects of HSK3486 Administration on Cardiac Repolarization in Healthy Subjects
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
Read the detailed description
This is a single-center, randomized, blinded (except moxifloxacin hydrochloride tablet), placebo and positive controlled study with a 6-sequence, three-period crossover design in healthy subjects. A blinded design is used for administration of HSK3486 and placebo, and an open-label design is used for moxifloxacin hydrochloride tablet.
Subjects meet the including criteria and none of exclusion criteria are randomized in equal proportion to one of 6 dosing sequences (see Table 2 for dosing sequences), and the study procedure consisted of 3 periods, with washout period of 5 days between periods.
Subjects are closely monitored on vital sign checking, 12-lead ECG, and Holter collection through out each treatment period.
- Conditions
- Anesthesia; Adverse Effect, Cardiac Arrhythmia
- Being tested
- HSK3486, Moxifloxacin Hydrochloride, Placebo
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HSK3486Drug
Also called Cipepofol
Study Drug
Moxifloxacin HydrochlorideDrug
Positive Control
PlaceboDrug
Negative Control
| Study group | Role | What they receive |
|---|---|---|
| HSK3486( study drug) | Experimental | One time, 0.4 mg/kg, IV bolus administration for 30 (±5) seconds Receives: Drug: HSK3486 |
| Placebo | Placebo comparator | One time, IV bolus administration for 30 (±5) seconds Receives: Drug: Placebo |
| Moxifloxacin hydrochloride | Active comparator | One time, 0.4 g oral administration with 240 mL of warm water on an empty stomach. Receives: Drug: Moxifloxacin Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change-from-baseline in QTc Interval
Corrected for HR using the individual QT correction method (QTcI) - ΔQTcI
Measured: From the base line ECG (D-2) to end of the period, up to 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start9 Apr 2024
- Primary completion19 May 2024
- Study completion26 Nov 2024
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anesthesia; Adverse EffectStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized, blinded (except moxifloxacin hydrochloride tablet), placebo and positive-controlled, 6-sequence, three-period crossover design
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 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
- NCT06795204
- Sponsor's protocol ID
- HSK3486-112
- Status last verified
- Dec 2025
- First submitted
- 22 Jan 2025
- Last updated
- 13 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41858914
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Positive and Placebo-Controlled Study to Evaluate the Effects of HSK3486 Administration on Cardiac Repolarization in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06795204
- Acronym / sponsor ID
- HSK3486-112
- Conditions
- Anesthesia; Adverse Effect, Cardiac Arrhythmia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Haisco-USA Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 19 May 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 27 Jan 2025 (actual)
- Results
- Posted 13 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a single-center, randomized, blinded (except moxifloxacin hydrochloride tablet), placebo and positive controlled study with a 6-sequence, three-period crossover design in healthy subjects. A blinded design is used for administration of HSK3486 and placebo, and an open-label design is used for moxifloxacin hydrochloride tablet.
Subjects meet the including criteria and none of exclusion criteria are randomized in equal proportion to one of 6 dosing sequences (see Table 2 for dosing sequences), and the study procedure consisted of 3 periods, with washout period of 5 days between periods.
Subjects are closely monitored on vital sign checking, 12-lead ECG, and Holter collection through out each treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized, blinded (except moxifloxacin hydrochloride tablet), placebo and positive-controlled, 6-sequence, three-period crossover design
| Arm | Type | Receives |
|---|---|---|
| HSK3486( study drug) | Experimental | Drug: HSK3486One time, 0.4 mg/kg, IV bolus administration for 30 (±5) seconds |
| Placebo | Placebo comparator | Drug: PlaceboOne time, IV bolus administration for 30 (±5) seconds |
| Moxifloxacin hydrochloride | Active comparator | Drug: Moxifloxacin HydrochlorideOne time, 0.4 g oral administration with 240 mL of warm water on an empty stomach. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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%.
Key exclusion criteria (37 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HSK3486Also: CipepofolStudy Drug | Drug | HSK3486( study drug) |
| Moxifloxacin HydrochloridePositive Control | Drug | Moxifloxacin hydrochloride |
| PlaceboNegative Control | Drug | Placebo |
Primary outcome
Change-from-baseline in QTc Interval
Time frame: From the base line ECG (D-2) to end of the period, up to 24 hours post-dose
Corrected for HR using the individual QT correction method (QTcI) - ΔQTcI
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41858914Kleiman 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.
- Individual participant dataSharing planned: No
Related trials for Anesthesia; Adverse Effect
RecruitingPhase 4
Propofol-Ketamine Versus Sevoflurane for Laryngeal Mask Anesthesia in Pediatric Cardiac Catheterization
Propofol, Ketamine
Active, not recruiting
Impact of Anesthesia Alarm Volume on Mental Workload in Surgical Trainees
Surgical Procedures, Noise
Not yet recruiting
Effect of Serratus and Pectoralis II Plane Block Versus Pectoralis II Alone on Acute Postoperative Pain After Mastectomy
Mastectomy, Mastectomy Plus Axillary Lymph Node Dissection
Enrolling by invitationPhase 1/2
This Study Aims to Determine Whether Lower Doses (4 µg) of Intrathecal Dexmedetomidine Can Provide Comparable Analgesic Benefits While Minimizing Adverse Hemodynamic Effects in Patients Encountered in Our Setup( Shifa International Hospital Islamabad).
Intrathecal Dexmedetomidine
RecruitingObservational study
Paramedian Incidence Angles in Spinal Anaesthesia
Anesthesia; Adverse Effect, Spinal and Epidural
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HSK3486 and Moxifloxacin Hydrochloride in people with Anesthesia; Adverse Effect and Cardiac Arrhythmia, run by Haisco-USA Pharmaceuticals, Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change-from-baseline in QTc Interval (time frame: From the base line ECG (D-2) to end of the period, up to 24 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06795204, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.