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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02125435
A Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects
25 de abril de 2014 actualizado por: Astellas Pharma Global Development, Inc.
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of ASP2408 Following Single Intravenous Doses in Healthy Subjects
The objective of this study is to assess the safety, tolerability, and pharmacokinetics (PK) of single ascending intravenous (IV) doses of ASP2408 in non-elderly, healthy male and female subjects and to evaluate the pharmacodynamics of ASP2408.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is single-dose escalation study composed of 8 sequential cohorts of healthy subjects receiving increasing doses of intravenously administered ASP2408 or matching placebo.
Subjects will be confined in the clinic for 8 days.
Tipo de estudio
Intervencionista
Inscripción (Actual)
65
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
-
-
Maryland
-
Baltimore, Maryland, Estados Unidos, 21225
- PAREXEL International
-
-
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
Inclusion Criteria:
- Subject weighs at least 50 kg, and has a body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.
- Results of subject's 12-lead electrocardiogram (ECG) are normal or, if abnormal, the abnormality is not clinically significant as determined by the investigator.
- Female subject must be at least two years postmenopausal OR surgically sterile (with documentation provided by a healthcare professional) and not pregnant or lactating.
- Male subject agrees to the use of male condoms until the end of study or 60 days post dose, whichever is longer.
- Subject is highly likely to comply with the protocol and complete the study.
Exclusion Criteria:
- Subject has a history of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy excluding adequately treated non-melanoma skin cancer.
- Subject has a history of severe allergic or anaphylactic reactions.
- Subject is a female of child-bearing potential.
- Subject has a history of consuming more than 14 units of alcoholic beverages per week or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years (Note: one unit = 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits).
- Subject has a positive test for alcohol or drugs of abuse.
- Subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check-in.
- Subject has a past history of opportunistic infection.
- Subject has a supine mean systolic blood pressure < 90 or > 160 mmHg and a mean diastolic blood pressure < 50 or > 90 mmHg, or mean pulse rate higher than 100 beats per min (bpm).
- Subject is known positive for human immunodeficiency virus (HIV) antibody.
- Subject has a positive TB skin test or Quantiferon Gold test or T-SPOT® test at Screening.
- Subject has a positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg), or positive hepatitis B core antibody.
Subject's laboratory test results:
- alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST), are greater than 1.5 times the upper limit of normal
- are outside the normal limits and considered by the investigator to be clinically significant with regard to the remaining per-protocol laboratory tests.
- Subject received any vaccine within 60 days prior to study drug administration.
- Subject received any systemic immunosuppressant agent within 2 months prior to study drug administration.
- Subject has previously received any antibody or therapeutic biologic product prior to study drug administration.
- Subject received any systemic steroid within 2 months or steroid inhaler within 1 month prior to study drug administration.
- Subject has had treatment with prescription, non-prescription or complementary and alternative medicines (CAM) within 14 days prior to study drug administration.
- Subject has received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration.
- Subject is participating in another clinical trial or has participated in another dose group of the current trial.
- Subject has had any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission on Day -1.
- Subject has a history of heavy smoking or has used tobacco-containing products and nicotine or nicotine-containing products in the past six months.
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: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: ASP2408 dose escalation cohort
|
intravenous
|
Comparador de placebos: Placebo dose escalation cohort
|
intravenoso
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Pharmacokinetic parameter of ASP2408:AUClast
Periodo de tiempo: Days 1-8, 15, 22, 29, 43, 60, 90
|
Area Under the Concentration - Time curve from time 0 up to the last quantifiable concentration (AUClast)
|
Days 1-8, 15, 22, 29, 43, 60, 90
|
Pharmacokinetic parameter of ASP2408: AUCinf
Periodo de tiempo: Days 1 -8, 15, 22, 29, 43, 60, 90
|
Area Under the Concentration - Time curve from time 0 extrapolated to infinity (AUCinf)
|
Days 1 -8, 15, 22, 29, 43, 60, 90
|
Pharmacokinetic parameter of ASP2408:Cmax
Periodo de tiempo: Days 1-8, 15, 22, 29, 43, 60, 90
|
Maximum concentration (Cmax)
|
Days 1-8, 15, 22, 29, 43, 60, 90
|
Safety assessed by adverse events, laboratory tests, immunoglobulin, 12-lead electrocardiograms (ECGs), vital signs and anti-2408 antibody formulation
Periodo de tiempo: up to 90 days
|
up to 90 days
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Composite of pharmacokinetics of ASP2408: tmax, t1/2, Vz, CLtot
Periodo de tiempo: Days 1-8, 15, 22, 29, 43, 60, 90
|
Time to attain Cmax (tmax), apparent terminal elimination half-life (t1/2), Terminal phase volume (Vz), Total Body Clearance (CLtot)
|
Days 1-8, 15, 22, 29, 43, 60, 90
|
Pharmacodynamic parameters of ASP2408: CD80 and CD86 receptor occupancy
Periodo de tiempo: Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90
|
Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90
|
|
Total lymphocyte count
Periodo de tiempo: Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90
|
Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90
|
|
Peripheral lymphocyte subset quantification
Periodo de tiempo: Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90
|
Days 1-3, 5, 8, 15, 22, 29, 43, 60, 90
|
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
1 de enero de 2011
Finalización primaria (Actual)
1 de mayo de 2012
Finalización del estudio (Actual)
1 de mayo de 2012
Fechas de registro del estudio
Enviado por primera vez
25 de abril de 2014
Primero enviado que cumplió con los criterios de control de calidad
25 de abril de 2014
Publicado por primera vez (Estimar)
29 de abril de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
29 de abril de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
25 de abril de 2014
Última verificación
1 de abril de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2408-CL-0101
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. .