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

NCT03866577 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-05-28

Study results available
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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.

Conditions

  • Immune Thrombocytopenic Purpura (ITP)

Interventions

BIOLOGICAL

Biological: M254

M254 administered as intravenous infusion

DRUG

Placebo

Placebo administered as intravenous infusion

BIOLOGICAL

Intravenous immunoglobulin (IVIg)

IVIg administered as intravenous infusion

Sponsors & Collaborators

  • Momenta Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Momenta General Queries · Momenta Pharmaceuticals, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-21
Primary Completion
2021-06-09
Completion
2021-06-09
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Hungary
  • Italy
  • Netherlands
  • Poland
  • Spain

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03866577 on ClinicalTrials.gov