Effects of HSK3486 on Cardiac Repolarization in Health Subjects (TQT) (NCT06795204) | Clinical Trial Compass
CompletedPhase 1
Effects of HSK3486 on Cardiac Repolarization in Health Subjects (TQT)
China48 participantsStarted 2024-04-09
Plain-language 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
Who can participate
Age range18 Years – 45 Years
SexALL
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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 (\< 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.
What they're measuring
1
Change-from-baseline in QTc Interval
Timeframe: From the base line ECG (D-2) to end of the period, up to 24 hours post-dose
✕. 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.