Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

18 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

34

Fase

  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • California
      • Glendale, California, Estados Unidos, 91206
        • California Clinical Trials Medical Group, Inc.

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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
Experimental: 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
Comparador de placebos: 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
Comparador activo: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline QTcF (ΔQTcF)
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change from baseline in QTc
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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
Periodo de tiempo: 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.
Periodo de tiempo: 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.
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

25 de septiembre de 2024

Finalización primaria (Actual)

16 de diciembre de 2024

Finalización del estudio (Actual)

23 de diciembre de 2024

Fechas de registro del estudio

Enviado por primera vez

4 de septiembre de 2024

Primero enviado que cumplió con los criterios de control de calidad

9 de septiembre de 2024

Publicado por primera vez (Actual)

19 de septiembre de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

18 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir