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BIIB033

Safety Study of BIIB033 in Subjects With Multiple Sclerosis

Ensayo de BIOGEN INC. en Esclerosis multiple remitente-recurrente.

Más ensayos de: Esclerosis múltiple remitente-recurrente · Esclerosis múltiple.

Fase

Fase 1

Estado

Completado

Participantes

47

previstos

Centros

1

Fin del objetivo primario

abr 2012

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, triple ciego. Comenzó en oct 2010.

Qué mide

Evaluate safety and tolerability profile of two IV infusions of BIIB033 in subjects with MS (For duration of study / 6 months) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroThe main purpose of the study is to evaluate the safety, tolerability, and pharmacokinetic profile of two intravenous infusions of BIIB033 administered two weeks apart in subjects with MS. Approximately 42 MS subjects are planned to be enrolled in the study in 7 separate groups (i.e., 6 subjects per group). Each subsequent group will be administered a higher dose of BIIB033. Before a higher dose group is allowed to start, a Drug Safety Review Committee will review all safety data from previous groups enrolled, as well as data from another study where BIIB033 is being administered to healthy volunteers (215HV101).

Más ensayos de BIIB

Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01244139), actualizada en ene 2017.