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

18. juni 2026 oppdatert av: Shanghai Ark Biopharmaceutical Co., Ltd.

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

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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

34

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • California
      • Glendale, California, Forente stater, 91206
        • California Clinical Trials Medical Group, Inc.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Treatment T (Therapeutic dose)
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)
Active Substance: Ziresovir, Pharmaceutical Form: Suspension, Route of Administration: Oral
Eksperimentell: Treatment ST (Supratherapeutic dose)
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)
Active Substance: Ziresovir, Pharmaceutical Form: Suspension, Route of Administration: Oral
Placebo komparator: Treatment P (Placebo)
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)
Active Substance: Placebo, Pharmaceutical Form: Suspension, Route of Administration: Oral
Aktiv komparator: Treatment PC (positive control)
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)
Active Substance: Moxifloxacin hydrochloride Pharmaceutical Form: Tablet Route of Administration: Oral

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline QTcF (ΔQTcF)
Tidsramme: 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).
Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change from baseline in QTc
Tidsramme: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
Change from baseline in QTc using correction methods not chosen as the primary correction method if a substantial HR effect is observed
Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
Change from baseline in HR, PR, and QRS
Tidsramme: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
Change-from-baseline in HR, PR and QRS (ΔHR, ΔPR and ΔQRS).
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.
Tidsramme: Up to Day 8 of each treatment period (up to 31 days)
Incidence of treatment-emergent adverse events (TEAEs) and changes in laboratory safety tests, vital signs, and ECGs.
Up to Day 8 of each treatment period (up to 31 days)
Treatment-emergent changes in ECG Morphology
Tidsramme: Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
Treatment-emergent changes in ECG Morphology
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.
Tidsramme: 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.
Before dosing (Baseline) through 48 hours after the dose on Day 1 in each treatment period
Maximum observed plasma concentration (Cmax) of ziresovir
Tidsramme: 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
PK parameters of ziresovir and its metabolites including maximum observed plasma concentration (Cmax).
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.
Tidsramme: 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.
PK parameters of ziresovir and its metabolites including terminal elimination half-life (t1/2).
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.
Tidsramme: 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.
PK parameters of ziresovir and its metabolites including area under the curve (AUC).
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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: David Han, M.D., M.P.H, California Clinical Trials Medical Group

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

25. september 2024

Primær fullføring (Faktiske)

16. desember 2024

Studiet fullført (Faktiske)

23. desember 2024

Datoer for studieregistrering

Først innsendt

4. september 2024

Først innsendt som oppfylte QC-kriteriene

9. september 2024

Først lagt ut (Faktiske)

19. september 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

18. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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