Safety and tolerability of M254 in healthy volunteers and immune thrombocytopenia patients

This is an open-label two phase study through Momenta Pharmaceuticals, Inc., to look at the safety, tolerability, pharmacodynamics/pharmacokinetics of M254 in healthy patients compared to patients with persistent or chronic immune thrombocytopenia (ITP). M254 is a hypersialylated Immunoglobulin G (hsIgG), a compound believed to be much stronger than IVIg alone. This study is looking to recruit participants between the ages of 18-55 years. Participants can expect to receive either M254 or a placebo if they are healthy, and M254 either alone or in conjunction with IVIg if they have ITP. Administration of IVIg may be at the same time or weeks apart.

USA, Belgium, France, Germany, Hungary, Italy, Netherlands, Poland, Spain.


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