- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00192296
Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528 in Healthy Adult Volunteers
4 de febrero de 2014 actualizado por: MedImmune LLC
A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability,Immunogenicity, and Pharmacokinetics of MEDI-528, a Humanized Monoclonal Anti-Interleukin-9 Antibody, in Healthy Adult Volunteers
Phase I study to evaluate the safety and tolerability of escalating single IV doses of MEDI-528.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The primary objective of this Phase I study is to evaluate the safety and tolerability of escalating single IV doses of MEDI-528 administered to healthy adult volunteers.
Tipo de estudio
Intervencionista
Inscripción (Actual)
24
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
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Louisiana
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New Orleans, Louisiana, Estados Unidos
- MDS Pharma Services
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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
18 años a 49 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Males and females age 18 up to and including 49 years of age at the time of the first dose of study drug
- Weight < 89 kg
- Written informed consent obtained from the volunteer
- Healthy by medical history and physical examination
- Sexually active females, unless surgically sterile or at least one year post-menopausal, must use an effective method of avoiding pregnancy (including oral, injectable, transdermal or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap,abstinence, use of a condom by the sexual partner or sterile sexual partner) for 3 months before the first dose of study drug, and must agree to continue using such precautions through 84 days after their dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active males, unless surgically sterile, must likewise use an effective method of birth control (condom or abstinence) and must agree to continue using such precautions through 84 days after their dose of study drug.
- Use of common over-the-counter medications such as topical corticosteroids, decongestants, antihistamines, analgesics, and antacids is permitted unless, in the opinion of the investigator, it would interfere with either the volunteer's ability to complete the study or interpretation of study results.
- Ability to complete the follow-up period of 84 days
- Willing to forego other forms of experimental treatment during the study period of 84 days
Exclusion Criteria:
- Acute illnesses or evidence of significant active infection, such as fever ≥38.0°C (100.5°F) at the start of the study
- Use of prescription medications, other than contraceptives, in the 28-day period before Study Day 0
- Blood donation in excess of 400 mL within 6 months of the time of entry into the study
- History of use of tobacco products within 3 years of Study Day 0 or history of smoking of >10 pack-years
- History of immunodeficiency or receipt or current use of immunosuppressive drugs including systemic corticosteroids
- History of allergic disease or reactions likely to be exacerbated by any component of the Study Drug (described in the Investigator's Brochure)
- History of substance abuse that, in the opinion of the investigator, may compromise the ability of the study subject to complete the study and follow-up period
- Evidence of any systemic disease on physical examination
- Evidence of infection with hepatitis A, B, or C virus or HIV-1
- Receipt of immunoglobulins or blood products within 60 days of entering the study
- Receipt of any investigational drug therapy within 60 days of the first dose of study drug through Study Day 84 (use of licensed agents for indications not listed in the package insert is permitted)
- Any of the following: CBC: Hgb < 12.0 gm/dL; WBC < 4,000/mm3; platelet count <125,000/mm3 (or laboratory normal values); Na, K, Cl, CO2, AST, ALT, BUN, 4-hour fasting glucose, amylase, lipase, creatinine, troponin > upper limit of normal; other abnormal laboratory values in the screening panel which in the opinion of the principal investigator are judged to be clinically significant.
- Clinically significant abnormality, as determined by the investigator, on 12-lead electrocardiogram at the time of initial screening
- Elective surgery planned during the study period through Study Day 84
- Pregnancy (sexually active females must have a negative serum pregnancy test on the day of the first dose of the study drug, before dosing)
- Nursing mother
- The presence of any acute or chronic organ-specific condition or any concern, which in the opinion of the investigator, may interfere with the conduct or interpretation of the study
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: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: MEDI-528 0.3 mg/kg
MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
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MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
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Experimental: MEDI-528 1 mg/kg
MEDI-528 (1 mg/kg) administered as a single, IV dose
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MEDI-528 (1 mg/kg) administered as a single, IV dose
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Experimental: MEDI-528 3 mg/kg
MEDI-528 (3 mg/kg) administered as a single, IV dose
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MEDI-528 (3 mg/kg) administered as a single, IV dose
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Experimental: MEDI-528 9 mg/kg
MEDI-528 (9 mg/kg) administered as a single, IV dose
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MEDI-528 (9 mg/kg) administered as a single, IV dose
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidencia de eventos adversos
Periodo de tiempo: Días 0 - 84
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Número de participantes que experimentaron eventos adversos (incluye eventos adversos y eventos adversos graves)
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Días 0 - 84
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Incidencia de eventos adversos graves
Periodo de tiempo: Días 0 - 84
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Número de participantes que experimentaron eventos adversos graves
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Días 0 - 84
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Incidence of Abnormal Troponin Levels
Periodo de tiempo: Days 0, 7, 14, 21, and 28
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Number of participants with troponin levels greater than upper limit of normal (> 0.05 ng/mL)
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Days 0, 7, 14, 21, and 28
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence of Anti-drug Antibodies (ADA) to MEDI-528
Periodo de tiempo: Days 14, 28, 42, and 84
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Number of participants who had ADA detected at each time point
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Days 14, 28, 42, and 84
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Time to Observed Maximum Serum Concentration (Tmax)
Periodo de tiempo: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
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Tmax of MEDI-528
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Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
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Observed Maximum Serum Concentration (Cmax)
Periodo de tiempo: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
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Cmax of MEDI-528
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Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
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Area Under the Concentration Curve From Time Zero to Last Measurable Concentration [AUC(0-t)]
Periodo de tiempo: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
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AUC(0-t) of MEDI-528
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Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
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Area Under the Concentration Curve From Time Zero to Infinity [AUC(0-infinity)]
Periodo de tiempo: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
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AUC(0-infinity) of MEDI-528
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Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
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Percent of Total Area Under the Concentration Curve Extrapolated From Last Measurable Time to Infinity [AUC(Ext)]
Periodo de tiempo: Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
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AUC(ext) of MEDI-528
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Days 0 (prior to and after the end of the infusion, and at 1, 2, 4, 8, and 12 hours after the end of the infusion), 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
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Total Body Clearance (CL)
Periodo de tiempo: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
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CL of MEDI-528
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Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
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Half-life (T1/2)
Periodo de tiempo: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
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T1/2 of MEDI-528
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Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
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Terminal Phase Elimination Rate (Vz)
Periodo de tiempo: Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
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Vz of MEDI-528
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Days 0, 1, 3, 5, 7, 10, 14, 21, 28, 42, and 84
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Ramon Vargas, MD
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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
1 de agosto de 2004
Finalización primaria (Actual)
1 de febrero de 2005
Finalización del estudio (Actual)
1 de marzo de 2005
Fechas de registro del estudio
Enviado por primera vez
12 de septiembre de 2005
Primero enviado que cumplió con los criterios de control de calidad
12 de septiembre de 2005
Publicado por primera vez (Estimar)
19 de septiembre de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
6 de marzo de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
4 de febrero de 2014
Última verificación
1 de febrero de 2014
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- MI-CP105
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. .
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