Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients
Stopped early · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Immune Thrombocytopenic Purpura (ITP)
In brief
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 facts
- Study ID
- NCT03866577
- Run by
- Momenta Pharmaceuticals, Inc.
- People needed
- 50
- Starts
- 2018-12-21
- Expected to finish
- 2021-06-09
- Last updated by the study team
- 2025-05-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
Where it is running
- University of Southern California — Los Angeles, California, United States
- Oncology Institute of Hope and Innovation — Whittier, California, United States
- Lakes Research — Miami Lakes, Florida, United States
- University of South Florida — St. Petersburg, Florida, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Taussig Cancer Insititute Cleveland Clinic — Cleveland, Ohio, United States
- Ucl de Mont-Godinne — Yvoir, Belgium
- Debreceni Egyetem Klinikai Kozpont — Debrecen, Hungary
- Somogy Megyei Kaposi Mor Oktato Korhaz — Kaposvár, Hungary
- Pecsi Tudomanyegyetem — Pécs, Hungary
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori — Meldola, Italy
- Azienda Unita Sanitaria Locale di Ravenna — Ravenna, Italy
- Arcispedale Santa Maria Nuova - IRCCS — Reggio Emilia, Italy
- Policlinico Universitario Agostino Gemelli — Roma, Italy
- Ospedale 'Casa Sollievo della Sofferenza' - U.O. Ematologia- — San Giovanni Rotondo, Italy
- Universitair Medisch Centrum Groningen — Groningen, Netherlands
- PRA Health Sciences — Groningen, Netherlands
- Silesian Healthy Blood Clinic — Chorzów, Poland
- Samodzielny Publiczny Szpital Kliniczny Nr 1 — Lublin, Poland
- Szpital Wojewodzki w Opolu — Opole, Poland
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej MSW w Poznaniu im prof Ludwika Bierkowskiego — Poznan, Poland
- Uniwersytecki Szpital Kliniczny im Jana Mikulicza Radeckiego we Wroclawiu — Wroclaw, Poland
- Hosp Univ Vall D Hebron — Barcelona, Spain
- Hosp. Univ. de Burgos — Burgos, Spain
- Hosp. Regional. Carlos Haya — Málaga, Spain
Full record on ClinicalTrials.gov
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