Status:
TERMINATED
Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients
Lead Sponsor:
Momenta Pharmaceuticals, Inc.
Conditions:
Immune Thrombocytopenic Purpura (ITP)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 i...
Detailed Description
The Part A of the study is currently not accepting healthy volunteers as the recruitment for the part A has completed.
Eligibility Criteria
Inclusion
- 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 aged ≥18 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.
Exclusion
Key Trial Info
Start Date :
December 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 9 2021
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03866577
Start Date
December 21 2018
End Date
June 9 2021
Last Update
May 28 2025
Active Locations (28)
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1
University of Southern California
Los Angeles, California, United States, 90089
2
Oncology Institute of Hope and Innovation
Whittier, California, United States, 90603
3
Lakes Research
Miami Lakes, Florida, United States, 33014
4
University of South Florida
St. Petersburg, Florida, United States, 33701