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- Ensayo clínico NCT02555085
Single Ascending Doses of BIIB063 in Healthy Volunteers
17 de abril de 2017 actualizado por: Biogen
Phase 1 Randomized, Blinded, Placebo-Controlled Study of Single Ascending Doses of BIIB063 in Healthy Volunteers
The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) doses and a single subcutaneous (SC) dose of BIIB063 in healthy volunteers.
The secondary objectives of the study are to estimate the PK parameters of single ascending IV doses of BIIB063; to estimate the PK parameters and absolute bioavailability (F) of a single SC dose of BIIB063; and to evaluate the immunogenicity of single ascending doses of BIIB063.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
29
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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West Yorkshire
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Leeds, West Yorkshire, Reino Unido, LD2 9LH
- Research Site
-
-
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 55 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Key Inclusion Criteria:
- All male subjects and all female subjects of childbearing potential must practice at least 1 highly effective method of contraception (i.e., contraceptive measure with a failure rate of <1% per year; estrogen-containing contraceptives are prohibited) during the study and be willing and able to continue contraception for 4 months after being dosed with study treatment. Male subjects must also be willing to refrain from sperm donation for at least 4 months after the last dose of study treatment. Male subjects must not have unprotected sexual intercourse with a female who is pregnant or breastfeeding during the study.
- Must have a body mass index between 18 and 30 kg/m2, inclusive.
- Must be in good health as determined by the Investigator, based on medical history, physical examination, and 12-lead ECG.
Key Exclusion Criteria:
- History of or positive test result at screening for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
- History of any clinically significant cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major disease, as determined by the Investigator.
- Personal or family history of cardiovascular disease under the age of 50 years, inherited disorder of coagulation (e.g., Factor V Leiden, protein C or S deficiency), or anti-phospholipid Ab syndrome (APS).
- History of meningococcal vaccination or meningococcal meningitis, or history of hypersensitivity to single components of meningococcal vaccines (including MENVEO), any other CRM197, diphtheria toxoid, or meningococcal-containing vaccine.
- History of tuberculosis (TB) or positive QuantiFERON®-TB Gold test
- Personal history of thromboembolic events
- Treatment with any prescription or over-the-counter medication within 14 days prior to randomization (excluding vitamins, dietary supplements, herbal preparations, progestin-only birth control, and paracetamol up to 4 g/day for no more than 5 consecutive days).
- Current enrollment or a plan to enroll in any interventional clinical study in which an investigational treatment or approved therapy for investigational use is administered within 3 months
- Current enrollment or a plan to enroll in any other drug, biologic or device clinical study, or treatment with an investigational drug or approved therapy for investigational use within 3 months
- Blood donation (1 unit or more) within 3 months prior to randomization.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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 paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: IV Dose 1
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
|
Single ascending IV dose
Dosís única
|
Experimental: IV Dose 2
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
|
Single ascending IV dose
Dosís única
|
Experimental: IV Dose 3
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
|
Single ascending IV dose
Dosís única
|
Experimental: IV Dose 4
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
|
Single ascending IV dose
Dosís única
|
Experimental: IV Dose 5
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
|
Single ascending IV dose
Dosís única
|
Experimental: IV Dose 6
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
|
Single ascending IV dose
Dosís única
|
Experimental: IV Dose 7
Single ascending IV dose or matching placebo based on body weight recorded on Day 1
|
Single ascending IV dose
Dosís única
|
Experimental: SC Dose
Single SC dose or matching placebo
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Single ascending IV dose
Dosís única
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Number of participants experiencing Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: Up to week 12
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Up to week 12
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Number of participants with clinically significant laboratory assessment abnormalities
Periodo de tiempo: Up to week 12
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Up to week 12
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Number of participants with clinically significant Vital sign abnormalities
Periodo de tiempo: Up to week 12
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Up to week 12
|
Number of participants with clinically significant 12-lead electrocardiograms (ECGs) abnormalities
Periodo de tiempo: Up to week 12
|
Up to week 12
|
Number of participants with clinically significant physical examination abnormalities
Periodo de tiempo: Up to week 12
|
Up to week 12
|
Change in antibody titers of vaccine immunization for tetanus
Periodo de tiempo: Up to week 12
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Up to week 12
|
Change in antibody titers of vaccine immunization for diphtheria
Periodo de tiempo: Up to week 12
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Up to week 12
|
Change in antibody titers of vaccine immunization for pneumococcus
Periodo de tiempo: Up to week 12
|
Up to week 12
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
PK parameter of single-ascending IV doses of BIIB063: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
Periodo de tiempo: Up to week 12
|
Up to week 12
|
PK parameter of single-ascending IV doses of BIIB063: Area under the concentration-time curve from time zero to infinity (AUCinf)
Periodo de tiempo: Up to week 12
|
Up to week 12
|
PK parameter of single-ascending IV doses of BIIB063: Maximum observed concentration (Cmax)
Periodo de tiempo: Up to week 12
|
Up to week 12
|
PK parameter of single-ascending IV doses of BIIB063: Time to reach maximum observed concentration (Tmax)
Periodo de tiempo: Up to week 12
|
Up to week 12
|
PK parameter of single-ascending IV doses of BIIB063: Terminal elimination half-life (t1/2)
Periodo de tiempo: Up to week 12
|
Up to week 12
|
PK parameter of single-ascending IV doses of BIIB063: Clearance (CL)
Periodo de tiempo: Up to week 12
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Up to week 12
|
PK parameter of single-ascending IV doses of BIIB063: Volume of distribution at steady state (Vss)
Periodo de tiempo: Up to week 12
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Up to week 12
|
PK parameter of a single SC dose of BIIB063: Area under the concentration-time curve from time zero to the time of the last measurable sample (AUClast)
Periodo de tiempo: Up to week 12
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Up to week 12
|
PK parameter of a single SC dose of BIIB063: Area under the concentration-time curve from time zero to infinity (AUCinf)
Periodo de tiempo: Up to week 12
|
Up to week 12
|
PK parameter of a single SC dose of BIIB063: Maximum observed concentration (Cmax)
Periodo de tiempo: Up to week 12
|
Up to week 12
|
PK parameter of a single SC dose of BIIB063: Time to reach maximum observed concentration (Tmax)
Periodo de tiempo: Up to week 12
|
Up to week 12
|
PK parameter of a single SC dose of BIIB063: Terminal elimination half-life (t1/2)
Periodo de tiempo: Up to week 12
|
Up to week 12
|
PK parameter of a single SC dose of BIIB063 Apparent total body clearance (CL/F)
Periodo de tiempo: Up to week 12
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Up to week 12
|
PK parameter of a single SC dose of BIIB063: Apparent volume of distribution during terminal elimination phase (Vz/F)
Periodo de tiempo: Up to week 12
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Up to week 12
|
PK parameter of a single SC dose of BIIB063: Absolute Bioavailability (F)
Periodo de tiempo: Up to week 12
|
Up to week 12
|
Number of participants with positive serum anti-BIIB063 antibodies
Periodo de tiempo: Up to week 12
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Up to week 12
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Percentage of participants with positive anti-BIIB063 titers within 12 weeks after administration of BIIB063
Periodo de tiempo: Up to 12 weeks
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Up to 12 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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)
30 de septiembre de 2015
Finalización primaria (Actual)
1 de junio de 2016
Finalización del estudio (Actual)
1 de junio de 2016
Fechas de registro del estudio
Enviado por primera vez
27 de agosto de 2015
Primero enviado que cumplió con los criterios de control de calidad
17 de septiembre de 2015
Publicado por primera vez (Estimar)
21 de septiembre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de abril de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
17 de abril de 2017
Última verificación
1 de abril de 2017
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 234HV101
- 2015-001283-18 (Número EudraCT)
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. .