Healthy VolunteersPhase 1NCT06591845

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

A Phase 1 study testing Ziresovir 125 mg, Ziresovir 500 mg and Moxifloxacin hydrochloride tablet 400 mg in people with Healthy Volunteers, run by Shanghai Ark Biopharmaceutical Co., Ltd. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Ziresovir 125 mg, Ziresovir 500 mg and Moxifloxacin hydrochloride tablet 400 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 25 Sep 2024to 23 Dec 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

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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.
Systolic blood pressure (BP) \&gt; 140 mmHg or \&lt; 90 mmHg, or diastolic BP \&gt; 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 \&gt;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.

Trial locations and contacts

1 site in 1 country.

United States1 site

California Clinical Trials Medical Group, Inc.
Glendale, California, 91206

Other trials in United States

About this study

Official title: A Single-Center, Randomized, Partially Double-Blind, Placebo- and Active-Controlled, Four-period Crossover, Thorough QT/QTc (TQT) Clinical Study to Evaluate the Effects of Ziresovir on Cardiac Repolarization in Healthy Subjects

Read the 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. Ziresovir and placebo will be administered in a double-blind manner, while moxifloxacin hydrochloride tablets will be administered in as open-label.

Thirty-two subjects meeting all inclusion criteria and none of the exclusion criteria will be randomized into 1 of 12 dosing sequences, each consisting of 4 periods with an 8-day washout period in-between.

Conditions: Healthy Volunteers
Being tested: Ziresovir 125 mg, Ziresovir 500 mg, Placebo, Moxifloxacin hydrochloride tablet 400 mg
Keywords: QT/QTc (TQT) Clinical Study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ziresovir 125 mgDrug
Active Substance: Ziresovir, Pharmaceutical Form: Suspension, Route of Administration: Oral
Ziresovir 500 mgDrug
Active Substance: Ziresovir, Pharmaceutical Form: Suspension, Route of Administration: Oral
PlaceboDrug
Active Substance: Placebo, Pharmaceutical Form: Suspension, Route of Administration: Oral
Moxifloxacin hydrochloride tablet 400 mgDrug
Active Substance: Moxifloxacin hydrochloride Pharmaceutical Form: Tablet Route of Administration: Oral

Study groups in NCT06591845
Study group	Role	What they receive
Treatment T (Therapeutic dose)	Experimental	The subjects will receive a ziresovir 125 mg as single dose on Day 1 (Period 1) or Day 9 (Period 2) or Day 17 (Period 3) or Day 25 (Period 4) Receives: Drug: Ziresovir 125 mg
Treatment ST (Supratherapeutic dose)	Experimental	The subjects will receive a ziresovir 500 mg as single dose on Day 1 (Period 1) or Day 9 (Period 2) or Day 17 (Period 3) or Day 25 (Period 4) Receives: Drug: Ziresovir 500 mg
Treatment P (Placebo)	Placebo comparator	The subjects will receive a placebo as single dose on Day 1 (Period 1) or Day 9 (Period 2) or Day 17 (Period 3) or Day 25 (Period 4) Receives: Drug: Placebo
Treatment PC (positive control)	Active comparator	The subjects will receive a moxifloxacin hydrochloride tablet 400 mg as single dose on Day 1 (Period 1) or Day 9 (Period 2) or Day 17 (Period 3) or Day 25 (Period 4) Receives: Drug: Moxifloxacin hydrochloride tablet 400 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline QTcF (ΔQTcF)
The primary ECG endpoint is the change from baseline in the QT interval corrected for heart rate (HR) using the Fridericia method (ΔQTcF).
Measured: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period

Secondary outcomes (8)

Change from baseline in QTc
Change from baseline in QTc using correction methods not chosen as the primary correction method if a substantial HR effect is observed
Measured: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
Change from baseline in HR, PR, and QRS
Change-from-baseline in HR, PR and QRS (ΔHR, ΔPR and ΔQRS).
Measured: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
Incidence of treatment-emergent adverse events (TEAEs) and changes in laboratory safety tests, vital signs, and ECGs.
Incidence of treatment-emergent adverse events (TEAEs) and changes in laboratory safety tests, vital signs, and ECGs.
Measured: Up to Day 8 of each treatment period (up to 31 days)
Treatment-emergent changes in ECG Morphology
Treatment-emergent changes in ECG Morphology
Measured: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
Categorical outliers for QTcF/QTcI/QTcS, HR, PR, and QRS.
Categorical outliers for QTcF/QTcI/QTcS, HR, PR, and QRS.
Measured: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
Maximum observed plasma concentration (Cmax) of ziresovir
PK parameters of ziresovir and its metabolites including maximum observed plasma concentration (Cmax).
Measured: Pre-dose within 1 hour and at 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours post-dose during each period
Terminal elimination half-life (t1/2) of ziresovir.
PK parameters of ziresovir and its metabolites including terminal elimination half-life (t1/2).
Measured: Pre-dose within 1 hour and at 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours post-dose during each period.
Area under the curve (AUC) of ziresovir.
PK parameters of ziresovir and its metabolites including area under the curve (AUC).
Measured: Pre-dose within 1 hour and at 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours post-dose during each period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Sep 202423 Dec 2024

First posted19 Sep 2024
Study start25 Sep 2024
Primary completion16 Dec 2024
Study completion23 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: This clinical study will last for a total of 59 days, including a 26-day screening period, admission day (Day -2) preceding the first treatment period, 4 treatment periods with 8 days washout in-between and a safety follow-up period (7 ± 1 days after the last dose).
Masking: Single blind
Who is masked: Participant
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06591845
Sponsor's protocol ID: AK0529-3004
Status last verified: Jun 2026
First submitted: 4 Sep 2024
Last updated: 22 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Randomized, Partially Double-Blind, Placebo- and Active-Controlled, Four-period Crossover, Thorough QT/QTc (TQT) Clinical Study to Evaluate the Effects of Ziresovir on Cardiac Repolarization in Healthy Subjects
ClinicalTrials.gov ID: NCT06591845
Acronym / sponsor ID: AK0529-3004
Conditions: Healthy Volunteers
Keywords: QT/QTc (TQT) Clinical Study
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: Shanghai Ark Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 25 Sep 2024 (actual)
Primary completion: 16 Dec 2024 (actual)
Study completion: 23 Dec 2024 (actual)
First posted: 19 Sep 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 4
Model description: This clinical study will last for a total of 59 days, including a 26-day screening period, admission day (Day -2) preceding the first treatment period, 4 treatment periods with 8 days washout in-between and a safety follow-up period (7 ± 1 days after the last dose).

Arm	Type	Receives
Treatment T (Therapeutic dose)	Experimental	Drug: Ziresovir 125 mgThe subjects will receive a ziresovir 125 mg as single dose on Day 1 (Period 1) or Day 9 (Period 2) or Day 17 (Period 3) or Day 25 (Period 4)
Treatment ST (Supratherapeutic dose)	Experimental	Drug: Ziresovir 500 mgThe subjects will receive a ziresovir 500 mg as single dose on Day 1 (Period 1) or Day 9 (Period 2) or Day 17 (Period 3) or Day 25 (Period 4)
Treatment P (Placebo)	Placebo comparator	Drug: PlaceboThe subjects will receive a placebo as single dose on Day 1 (Period 1) or Day 9 (Period 2) or Day 17 (Period 3) or Day 25 (Period 4)
Treatment PC (positive control)	Active comparator	Drug: Moxifloxacin hydrochloride tablet 400 mgThe subjects will receive a moxifloxacin hydrochloride tablet 400 mg as single dose on Day 1 (Period 1) or Day 9 (Period 2) or Day 17 (Period 3) or Day 25 (Period 4)

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ziresovir 125 mgActive Substance: Ziresovir, Pharmaceutical Form: Suspension, Route of Administration: Oral	Drug	Treatment T (Therapeutic dose)
Ziresovir 500 mgActive Substance: Ziresovir, Pharmaceutical Form: Suspension, Route of Administration: Oral	Drug	Treatment ST (Supratherapeutic dose)
PlaceboActive Substance: Placebo, Pharmaceutical Form: Suspension, Route of Administration: Oral	Drug	Treatment P (Placebo)
Moxifloxacin hydrochloride tablet 400 mgActive Substance: Moxifloxacin hydrochloride Pharmaceutical Form: Tablet Route of Administration: Oral	Drug	Treatment PC (positive control)

Primary outcome

Change from baseline QTcF (ΔQTcF)
Time frame: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
The primary ECG endpoint is the change from baseline in the QT interval corrected for heart rate (HR) using the Fridericia method (ΔQTcF).

8 secondary outcomes

Change from baseline in QTc
Time frame: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
Change from baseline in HR, PR, and QRS
Time frame: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
Incidence of treatment-emergent adverse events (TEAEs) and changes in laboratory safety tests, vital signs, and ECGs.
Time frame: Up to Day 8 of each treatment period (up to 31 days)
Treatment-emergent changes in ECG Morphology
Time frame: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
Categorical outliers for QTcF/QTcI/QTcS, HR, PR, and QRS.
Time frame: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
Maximum observed plasma concentration (Cmax) of ziresovir
Time frame: Pre-dose within 1 hour and at 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours post-dose during each period
Terminal elimination half-life (t1/2) of ziresovir.
Time frame: Pre-dose within 1 hour and at 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours post-dose during each period.
Area under the curve (AUC) of ziresovir.
Time frame: Pre-dose within 1 hour and at 0.5 hour, 1 hour, 2 hours, 3 hours, 4 hours, 8 hours, 12 hours, 24 hours, 36 hours, 48 hours, and 72 hours post-dose during each period.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Han, M.D., M.P.H principal investigator

California Clinical Trials Medical Group

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline QTcF (ΔQTcF) (time frame: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06591845.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.