Not Yet RecruitingPhase 1

Thorough QT/QTc (TQT) Clinical Study to Evaluate the Effects of Ziresovir on Cardiac Repolarization in Healthy Subjects

32 participantsStarted 2024-09-15

Plain-language 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 cardiac repolarization in healthy subjects.

Who can participate

Age range18 Years – 50 Years

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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\&gt;220 ms, QRS\&gt;120 ms, HR\&lt; 50 bpm or \&gt;100 bpm, QTcF \&gt;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.

What they're measuring

Change from baseline QTcF (ΔQTcF)

Timeframe: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period

Trial details

NCT IDNCT06591845

SponsorShanghai Ark Biopharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-12-31

Contact for this trial

Sally Xiang

2150681677 sally.xiang@arkbiosciences.com

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