A Double-Blind, Placebo-Controlled, Single Ascending Intravenous Infusion Study of Recombinant Human Immunoglobulin M (rHIgM22) in Patients With Multiple Sclerosis (MS)
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.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : rHIgM22
Phase: Phase 1
Ages Eligible For Study:
- Able to give written informed consent, with adequate cognitive function to sign the IRBapproved informed consent - Meet diagnostic criteria for MS, as defined by revised (2010) McDonald criteria - Man or woman aged 18 to 70 years, inclusive - Women of childbearing potential must have a negative serum pregnancy test at the Screening Visit and - Women of childbearing potential and engaged in heterosexual relations must agree to practice adequate contraception for at least 60 days after study dosing. Women of childbearing potential and not engaged in heterosexual relations or not practicing adequate contraception must agree to remain abstinent for at least 60 days after study dosing practice adequate contraception for the duration of the study - Agree to remain in the hospital for the 48 hour post infusion observation period, and can be contacted in case of an emergency once discharged