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BG00010 IV

Phase 1 Subcutaneous Single and Multiple Ascending Dose Study of BG00010 (Neublastin)

Ensayo de BIOGEN INC. en Radiculopatia lumbar dolorosa · Sano.

Fase

Fase 1

Estado

Completado

Participantes

54

previstos

Centros

1

Fin del objetivo primario

ago 2014

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, doble ciego. Comenzó en abr 2013.

Qué mide

El numero de participantes con acontecimientos adversos (AE)/acontecimientos adversos graves (SAE) (hasta el dia 75)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe primary objective of the study is to evaluate the safety and tolerability of a range of single intravenous (IV) and subcutaneous (SC) doses of BG00010 in healthy volunteers, and a range of multiple SC doses of BG00010 in participants with painful lumbar radiculopathy. Secondary objectives of this study are to determine the single IV and SC dose pharmacokinetics (PK) profile of BG00010 in healthy volunteers including assessment of bioavailability by comparing SC exposure to IV exposure in each participant, to determine the multiple SC dose PK profiles of BG00010 in participants with painful lumbar radiculopathy, to assess the single IV and SC dose immunogenicity of BG00010 in healthy volunteers, to assess the multiple SC dose immunogenicity of BG00010 in participants with painful lumbar radiculopathy, and to assess the potential of BG00010 to reduce pain following multiple SC administrations in participants with painful lumbar radiculopathy.

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Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01842126), actualizada en feb 2015.