Summary:
This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects.
Qualified Participants Must:
• Be between 18 and 70 years of age
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Meet diagnostic criteria for MS, as defined by revised (2010) McDonald criteria
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Present with a clinical acute relapse defined as a new or worsening neurological symptoms attributable to MS preceded by a stable or improving neurological state of at least 30 days, not associated with fever or infection, lasting at least 24 hours and accompanied by an objective physical (neurological) exam finding as confirmed by the Investigator
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Have at least one new, identifiable, measurable and active lesion on MRI (Gd+) meeting the criteria of the imaging charter
Qualified Participants May Receive:
Study-related medical care and study medication at no cost and may be compensated for time and travel.