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BIIB023

Phase 1 Study to Evaluate the PK, Safety, Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Healthy Volunteers

Ensayo de BIOGEN INC. en Voluntarios sanos.

Fase

Fase 1

Estado

Completado

Participantes

48

previstos

Centros

2

Fin del objetivo primario

feb 2012

fecha real

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, cuádruple ciego. Comenzó en sep 2011.

Qué mide

AUC of BIIB023 (Participants will be followed for the duration of a study; an expected 71 days) (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroRationale for the Study: Phase 1 pharmacokinetic (PK) data is needed in Chinese and Japanese populations to support future clinical development of BIIB023 in China and Japan. Study Design: This is a single-dose study to assess the PK, safety, and tolerability of BIIB023 administered intravenously (IV) to adult Chinese, Japanese, and Caucasian healthy volunteers. The Caucasian group is included to allow comparison of PK data from different groups using data from the same study under the same controlled conditions. Subjects will be in the clinic for 48 hours around the time of dosing and in the study for up to 100 days.

Más ensayos de BIIB

Todos los de BIIB, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT01407406), actualizada en sep 2013.