Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients

  • STATUS
    Recruiting
  • End date
    Jun 2, 2022
  • participants needed
    70
  • sponsor
    Momenta Pharmaceuticals, Inc.
Updated on 2 April 2021
Investigator
The Medical Research Network, LLC
Primary Contact
Momenta Investigational Site (0.0 mi away) Contact
+29 other location
igiv
immune globulin

Summary

The purpose of this study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 after administration of a single ascending dose and repeat doses in healthy volunteers and immune thrombocytopenic purpura (ITP) patients. The pharmacodynamics of the drug will be measured as platelet response in patients with ITP.

Description

The Part A of the study is currently not accepting healthy volunteers as the recruitment for the part A has completed.

Details
Condition IDIOPATHIC THROMBOCYTOPENIC PURPURA, Autoimmune disease, Idiopathic Thrombocytopenic Purpura (ITP), Thrombocytopenic
Treatment Placebo, Intravenous immunoglobulin (IVIG), Biological: M254
Clinical Study IdentifierNCT03866577
SponsorMomenta Pharmaceuticals, Inc.
Last Modified on2 April 2021

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