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Heart check: experimental drug ziresovir put to the test in healthy adults

NCT ID NCT06591845

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 1 trial tested whether the experimental drug ziresovir affects the heart's electrical activity in 34 healthy adults. Participants received different doses of ziresovir, a placebo, and an active control (moxifloxacin) to compare effects. The main goal was to measure changes in the QT interval, a key heart rhythm safety marker. Results will help determine if ziresovir is safe for future studies in patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ziresovir
What this could lead to
If successful, this study could confirm that ziresovir is safe for the heart, supporting its use in treating respiratory infections.
What could go wrong
This is an early-phase safety study in healthy people, not patients. It only looks at heart effects and does not test if the drug works for any disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

34 people

The number who actually took part.

Started

Sep 2024

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. The subject voluntarily signed a written informed consent form. 2. Male or female; between 18 and 50 years old (inclusive). 3. 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). 4. 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. 5. The subject can communicate well with the investigator and is able to complete the study in compliance with the protocol. Exclusion Criteria: 1. 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. 2. 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. 3. Known or suspected malignancy. 4. 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. 5. Subjects who have donated blood or have had a blood loss ≥500 ml within 3 months prior to screening. 6. 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. 7. History of substance abuse (e.g., alcohol, licit or illicit drugs) within 1 year prior to screening. 8. 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. 9. Systolic blood pressure (BP) \> 140 mmHg or \< 90 mmHg, or diastolic BP \> 90 mmHg at screening or admission. 10. Serum potassium, calcium, or magnesium levels outside the normal range at screening or admission. 11. Positive blood alcohol test, positive urine cotinine test or positive urine drug abuse screening at screening or admission. 12. Engaged in strenuous exercise within 48 hours before randomization (e.g., marathon running, long-distance cycling, weightlifting). 13. 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). 14. 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). 15. Smoking or use of tobacco or nicotine-containing products within 6 months before screening. 16. Pregnant or lactating women or those with positive blood pregnancy test results.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • California Clinical Trials Medical Group, Inc.

    Glendale, California, 91206, United States

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