- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07612813
A Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adults
A Phase I, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacokinetics of AZD7760 in Healthy Japanese Adult Participants
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This is a Phase I, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety and PK of AZD7760, a mAb combination of suvratoxumab (labeled as MEDI4893) and AZD7745, in healthy Japanese adults. Two dosages of AZD7760 each administered as a single IV dose, will be assessed.
Study details include:
- A Screening Period of up to 28 days.
- A Dosing Period of 3 days, in which a single IV infusion will be given on Day 1.
- A Follow-up Period of 12 months from the time of administration of the study intervention.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: AstraZeneca Clinical Study Information Center
- Número de teléfono: 1-877-240-9479
- Correo electrónico: information.center@astrazeneca.com
Ubicaciones de estudio
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Sumida-ku, Japón, 130-0004
- Reclutamiento
- Research Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range of ≥ 18.0 to ≤ 30.0 kg/m2 (inclusive) at screening.
- Healthy Japanese participants with no clinically significant concomitant diseases or medications.
Exclusion Criteria:
- Known hypersensitivity to any component of the study intervention.
- Previous hypersensitivity, infusion-related reaction, or severe adverse reaction following administration of mAbs.
- Clinically significant bleeding disorder or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
- AST or ALT above 1.5 × ULN at screening.
- Estimated glomerular filtration rate < 90 mL/min/1.73 m2.
- Hemoglobin or platelet count below the lower limit of normal at screening.
- White blood cell counts outside normal reference ranges.
- History of malignancy other than treated non-melanoma skin cancers or locally treated cervical cancer in the previous 5 years.
- Any clinically significant abnormalities on 12-lead ECG at screening,
- Acute (time-limited) illness, including fever ≥ 38 °C (100.4 °F), one day prior to or on the day of planned dosing.
- Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy.
- Any condition that has the potential to increase clearance of the study intervention.
Blood donation or collection as follows:
- 400 mL whole blood donation within 12 weeks (males) or 16 weeks (females) prior to study drug administration.
- 200 mL whole blood donation within 4 weeks prior to study drug administration.
- Apheresis donation within 2 weeks prior to study drug administration.
- Absence of suitable veins for blood sampling and administration of study intervention.
- Any other condition that would compromise the safety of the participants.
- Any condition that might interfere with evaluation of the study intervention or interpretation of participant safety or study results.
- Any laboratory value in the screening panel that, in the opinion of the investigator, is clinically significant or might confound analysis of study results. Testing may be repeated once at the investigator's discretion.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Cohort 1 (AZD7760 Dose A)
Participants receive an IV infusion of AZD7760 Dose A on Day 1.
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Participants will receive AZD7760 via IV infusion.
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Experimental: Cohort 2 (AZD7760 Dose B)
Participants receive an IV infusion of AZD7760 Dose B on Day 1.
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Participants will receive AZD7760 via IV infusion.
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Comparador de placebos: Pooled Placebo
Participants receive an IV infusion of matching placebo on Day 1.
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Participants will receive matching placebo via IV infusion.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Occurrence of Adverse Events (AEs)
Periodo de tiempo: Day 1 to Day 181
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To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants.
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Day 1 to Day 181
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Occurrence of Medically-attended Adverse Events (MAAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)
Periodo de tiempo: Day 1 to Day 361
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To evaluate the safety of AZD7760 administered as a single IV Dose A or Dose B in healthy Japanese adult participants.
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Day 1 to Day 361
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Maximum observed serum (peak) drug concentration (Cmax)
Periodo de tiempo: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
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Day 1 to Day 361
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Time to reach peak or maximum observed concentration following drug administration (tmax)
Periodo de tiempo: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
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Day 1 to Day 361
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Terminal elimination half-life (t½λz)
Periodo de tiempo: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
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Day 1 to Day 361
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Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration (AUClast)
Periodo de tiempo: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
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Day 1 to Day 361
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Area under the concentration-time curve from time 0 to infinity (AUCinf)
Periodo de tiempo: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
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Day 1 to Day 361
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Volume of distribution at steady state (Vss)
Periodo de tiempo: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
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Day 1 to Day 361
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Volume of distribution based on the terminal phase (Vz)
Periodo de tiempo: Day 1 to Day 361
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To characterize the PK of AZD7760 in serum of healthy Japanese adult participants.
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Day 1 to Day 361
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Incidence of Anti-drug antibody (ADA)
Periodo de tiempo: Day 1 to Day 361
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To evaluate ADA responses to AZD7760 in serum of healthy Japanese adult participants
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Day 1 to Day 361
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- D7480C00003
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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