A Multiple-Dose, Open-Label, Phase 1, Pharmacokinetic, Pharmacodynamic, and Safety Study of Avonex® in Chinese Healthy Volunteer Subjects

Summary

Rationale for the Study: The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of Avonex in Chinese healthy volunteer subjects. Data from this study will be used to support registration of Avonex in China. Study Design: This is a multiple-dose, single-arm, open-label, PK/PD and safety study. Four weekly injections of Avonex will be administered intramuscularly (IM). Frequent (intensive) blood samples will be collected with the first and fourth injections of Avonex, and a sparse blood sample will be collected with the second and third injections of Avonex.

Timeline

Start

2011-08

Primary completion

2011-10

Completion

2011-10

Drugs

Indications

No indication recorded.