NCT03866577

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Momenta Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

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

Conditions

• Immune Thrombocytopenic Purpura (ITP)

Interventions

Type	Name	Description
BIOLOGICAL	Biological: M254	M254 administered as intravenous infusion
DRUG	Placebo	Placebo administered as intravenous infusion
BIOLOGICAL	Intravenous immunoglobulin (IVIg)	IVIg administered as intravenous infusion

Timeline

• Start date: 2018-12-21
• Primary completion: 2021-06-09
• Completion: 2021-06-09
• First posted: 2019-03-07
• Last updated: 2025-05-28
• Results posted: 2024-07-01

Locations

28 sites across 7 countries: United States, Belgium, Hungary, Italy, Netherlands, Poland, Spain

Regulatory

• FDA-regulated drug study