Status:
NOT_YET_RECRUITING
Thorough QT/QTc (TQT) Clinical Study to Evaluate the Effects of Ziresovir on Cardiac Repolarization in Healthy Subjects
Lead Sponsor:
Shanghai Ark Biopharmaceutical Co., Ltd.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This is a single-center, randomized, partially double-blind, placebo and active-controlled, 4-period crossover design thorough QT/QTc (TQT) clinical study to evaluate the effects of ziresovir on cardi...
Detailed Description
This clinical study is a single-center, randomized, partially double-blind, placebo- and active-controlled, four-period crossover design, with healthy subjects comprising the enrolled population. Zire...
Eligibility Criteria
Inclusion
- The subject voluntarily signed a written informed consent form.
- Male or female; between 18 and 50 years old (inclusive).
- Male subjects weighing ≥50 kg, female subjects weighing ≥45 kg, body mass index (BMI) between 19.0 and 30.0 kg/m2 (inclusive), BMI= weight (kg)/height2 (m2).
- Healthy, as defined by no clinically significant or relevant abnormalities identified by vital signs, physical examination, laboratory examination items, ECG, and other trial-related examinations at screening, admission or baseline day of each period as assessed by the investigator.
- The subject can communicate well with the investigator and is able to complete the study in compliance with the protocol.
Exclusion
- History of or evidence of clinically significant disorder, condition or disease not otherwise excluded that, in the opinion of the investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
- History of cardiovascular disease or risk factors for Torsade de Pointes (TdP) at screening, including but not limited to: unexplained syncope; heart failure; cardiomyopathy; hypertension; angina pectoris; myocardial infarction; hypokalemia; bradycardia or sick sinus syndrome; cardiac conduction abnormalities; personal or family history of long QT syndrome (LQTS); or family history of sudden death.
- Known or suspected malignancy.
- Known allergic reactions to study intervention (e.g., ziresovir or its drug excipients, moxifloxacin, fluoroquinolone antibiotics) or history of clinically significant multiple or severe drug allergies, food allergies.
- Subjects who have donated blood or have had a blood loss ≥500 ml within 3 months prior to screening.
- Subjects who have participated in a clinical trial evaluating an investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to screening.
- History of substance abuse (e.g., alcohol, licit or illicit drugs) within 1 year prior to screening.
- 12-lead ECG at screening or admission exceeding criteria: PR\>220 ms, QRS\>120 ms, HR\< 50 bpm or \>100 bpm, QTcF \>450 ms (male and female) (The mean of 3 triplicate ECGs timepoint measurement); or ECG abnormalities that are considered by the investigator to be abnormal and clinically significant.
- Systolic blood pressure (BP) \> 140 mmHg or \< 90 mmHg, or diastolic BP \> 90 mmHg at screening or admission.
- Serum potassium, calcium, or magnesium levels outside the normal range at screening or admission.
- Positive blood alcohol test, positive urine cotinine test or positive urine drug abuse screening at screening or admission.
- Engaged in strenuous exercise within 48 hours before randomization (e.g., marathon running, long-distance cycling, weightlifting).
- Intake of caffeinated beverages or food within 48 hours before randomization or a history of high caffeine consumption (e.g., in the last 3 months drinking \>5 cups of coffee/day).
- History of alcoholism or regular alcohol consumption within 1 year prior to screening, defined as more than 14 units (male) or 7 units (female) of alcohol per week (1 unit =360 mL of beer or 45 mL of spirits containing 40% alcohol or 150 mL of wine).
- Smoking or use of tobacco or nicotine-containing products within 6 months before screening.
- Pregnant or lactating women or those with positive blood pregnancy test results.
Key Trial Info
Start Date :
September 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06591845
Start Date
September 15 2024
End Date
December 31 2024
Last Update
September 19 2024
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