This is a Phase I, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study designed to evaluate safety, tolerability, pharmacokinetics, and immunogenicity of single intravenous (IV) administrations of rHIgM22 in patients with all clinical presentations of MS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
Administered via IV infusion
Acorda Investigational Site
Long Beach, California, United States
Acorda Investigational Site
Palo Alto, California, United States
Safety and tolerability of single ascending doses of the human monoclonal rHIgM22 in patients with MS.
Monitoring of adverse events (AEs) will be conducted throughout the study. Adverse events, including serious adverse events will be recorded in the case report forms (CRFs).
Time frame: 90 Days
Measure the pharmacokinetics (PK) of single ascending doses of rHIgM22
PK parameters will include; The maximum measured plasma concentration (Cmax), time to maximum plasma concentration (Tmax), half-life (T1/2), and the area under the concentration curve from time 0 to the concentration at last time point (AUC (0-last)).
Time frame: Day 1 through Day 180
Measure the pharmacodynamics of single ascending doses of rHIgM22 using the Expanded Disability Status Scale (EDSS)
Time frame: Day 1 through Day 180
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Acorda Investigational Site
Sacramento, California, United States
Acorda Investigational Site
Stanford, California, United States
Acorda Investigational Site
Aurora, Colorado, United States
Acorda Investigational Site
Centennial, Colorado, United States
Acorda Investigational Site
Indianapolis, Indiana, United States
Acorda Investigational Site
Kansas City, Kansas, United States
Acorda Investigational Site
Baltimore, Maryland, United States
Acorda Investigational Site
St Louis, Missouri, United States
...and 7 more locations