A Randomized, Blinded, Placebo-Controlled, Serial-Cohort, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With Multiple Sclerosis

The 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).

本研究的核心目的为评估间隔两周两次给药的BIIB033静脉输注制剂，在多发性硬化（multiple sclerosis，MS）受试者中的安全性、耐受性及药代动力学特征。本研究计划纳入约42名MS受试者，分为7个独立给药组（每组6名受试者）。后续每组将给予更高剂量的BIIB033。在更高剂量组获准启动给药前，药物安全审查委员会需审查已入组前序组别受试者的全部安全性数据，以及另一项将BIIB033给予健康志愿者的研究（215HV101）的相关数据。