Heart check: experimental drug ziresovir put to the test in healthy adults
NCT ID NCT06591845
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy volunteers are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Scientists probe the nerve highways behind strength gains
- New syphilis test kits put to the test with donated blood
- Can a copy of a blockbuster arthritis drug match the original? scientists test it in healthy people
- Novo nordisk tests Brand-New molecule in humans for the first time
- New sedative candidate goes Head-to-Head with propofol in early human test
- Can a Room-Temperature dairy drink build muscle?