- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00435604
A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase
Phase I Dose-Ranging Randomized Double-Blinded Controlled Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase
This Phase I, randomized, double-blinded, within-subject controlled, two-way crossover study comparing the time to inject (flow rate), safety, and tolerability of a subcutaneously (SC) administered, viscous antibody solution of with and without human recombinant hyaluronidase (rHuPH20) in volunteer subjects.
The study hypothesizes that the time required to complete a 20-mL SC injection of a viscous antibody with rHuPH20 will be comparable or shorter than the time required for the injection without rHuPH20.
Descripción general del estudio
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 1
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Volunteers of either sex, age 18 to 65 years, inclusive.
- Intact normal skin on both upper extremities without tattoos or potentially obscuring pigmentation or lesions.
- Vital signs (BP, HR, temperature, respiratory rate) within normal range.
- Metabolic panel (e.g., sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose, calcium, AST, ALT, alkaline phosphatase, total bilirubin, albumin, and total protein) within normal range within 7 days of injection.
- A negative serum or urine pregnancy test (if female of child-bearing potential) within 7 days of injection.
- Female subjects of child-bearing potential must be practicing effective birth control or abstinence currently and plan to continue to do so for the duration of the study.
- Decision-making capacity and willingness and ability to comply with the requirements for full completion of the trial.
- Willingness and ability to sign an informed consent document.
Exclusion Criteria:
- Upper extremity edema.
- Upper extremity pathology that could interfere with any protocol-specified outcome assessment (e.g., cellulitis, lymphatic disorder or prior surgery, preexisting pain syndrome, previous mastectomy and/or axillary lymph node dissection, etc.).
- Contraindication to an antibody, such as known history of anaphylactic or severe systemic reactions.
- Known predisposition to renal insufficiency or renal failure, including diabetes mellitus, volume depletion, sepsis, paraproteinemia, and subjects receiving known nephrotoxic drugs.
- Known allergy to hyaluronidase or any other ingredient in the formulation of Hylenex.
- Known allergy to bee or vespid venom.
- Known coagulopathy.
- Pregnancy or breast-feeding woman.
- Known clinically significant cardiovascular, gastrointestinal, hepatic, neurological, psychiatric, endocrine, cancer, HIV infection, diabetes mellitus, intercurrent illness such as influenza, or other major systemic disease that would unduly risk the subject's safety or interfere with the interpretation of results.
- Participation in a study of any investigational drug or device within 30 days of enrollment in this study.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
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The time to inject 20 mL of a viscous antibody solution with and without rHuPH20.
|
Medidas de resultado secundarias
Medida de resultado |
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Assess the time required for a subcutaneous injection with various doses of rHuPH20, safety, tolerability.
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anoshie Ratnayake, M.D., Principal Investigator
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- HZ2-07-01
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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