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NCT03866577 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients
A Phase 1 study, sponsored by Momenta Pharmaceuticals.
- Terminated
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT03866577 is a Phase 1 study that was terminated before completion, run by Momenta Pharmaceuticals. The registered enrollment target is 50 participants.
The verdict
NCT03866577, a Phase 1 study, was terminated before completion, sponsored by Momenta Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study 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.
Interventions
- DRUG Placebo
- BIOLOGICAL Biological: M254
- BIOLOGICAL Intravenous immunoglobulin (IVIg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2018-12-21 |
| Est. Completion | 2021-06-09 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03866577
The ClinicalTrials.gov registry entry for NCT03866577 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Momenta Pharmaceuticals, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03866577 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03866577 about?
NCT03866577 is a clinical study titled "Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients". 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 ...
What is the current status of trial NCT03866577?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2018-12-21. Estimated completion is 2021-06-09.
What interventions are being tested in trial NCT03866577?
The interventions under investigation include: Placebo (DRUG), Biological: M254 (BIOLOGICAL), Intravenous immunoglobulin (IVIg) (BIOLOGICAL).
Who is sponsoring clinical trial NCT03866577?
This trial is sponsored by Momenta Pharmaceuticals, which has 8 total clinical trials registered on ClinicalTrials.gov.
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