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

Status:	Recruiting
Conditions:	Hematology, Hematology, Hematology
Therapuetic Areas:	Hematology
Healthy:	No
Age Range:	18 - 64
Updated:	4/6/2019
Start Date:	January 28, 2019
End Date:	October 2020
Contact:	Momenta General Queries
Email:	ClinicalTrialInfo@momentapharma.com
Phone:	+1 617-491-9700

A 4-part Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of M254 in Healthy Volunteers and in Patients With Immune Thrombocytopenic Purpura

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.

Key Criteria for Healthy Volunteers: Subject must be between the ages of 18 and 55 years;
healthy as indicated by medical history, physical examination, vital signs, clinical
laboratory tests, and 12-lead electrocardiogram, and all abnormal findings are assessed as
not clinically significant by the Investigator; not pregnant or breastfeeding; and no other
clinically relevant abnormalities currently or in their history that the Investigator would
deem them ineligible to participate.

Key Criteria for Immune Thrombocytopenic Purpura (ITP) Patients: Patient must be between
the ages of 18 to 64 years and diagnosed with ITP at least 3 months prior to screening,
stable maintenance therapy for at least 4 weeks prior to the first study visit, not
pregnant or breastfeeding, and no other clinically relevant abnormalities currently or in
their history that the Investigator would deem them ineligible to participate.

We found this trial at

sites

Momenta Investigational Site

Durham, North Carolina 27710

from

Durham, NC