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NCT01551316 · ClinicalTrials.gov registry record · Phase 1
Safety Study to Evaluate MN-221 in Chronic Obstructive Pulmonary Disease (COPD) Patients
A Phase 1 study, sponsored by MediciNova.
- Completed
- Registry status
- Phase 1
- Development phase
- 19
- Enrollment target
NCT01551316 is a Phase 1 study that has completed, run by MediciNova. The registered enrollment target is 19 participants.
The verdict
NCT01551316, a Phase 1 study, has completed, sponsored by MediciNova.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 19 participants
- Enrollment target
Study Summary
In MediciNova's clinical development plan for MN-221, it was recognized that treatment of COPD exacerbations may necessitate more than one single i.v. infusion and that patients in this population may have more co-morbidities (and concomitant medications) than has been generally studied so far. Thus, the primary objective of this clinical study is to determine the repeated administration safety and tolerability of intravenous (i.v.) MN-221 compared to placebo with repeated administration over several days in moderate to severe COPD patients who may also have co-morbidities and concomitant medications (CM) common in this population. Secondary outcomes include pharmacokinetics (PK) and preliminary efficacy (FEV1). This Phase 1b trial follows naturally upon a Phase 1b COPD trial completed last year (MN-221-CL-010) and is additionally well-supported by relevant animal safety data and human clinical trial information.
Interventions
- DRUG Placebo
- DRUG MN-221
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2012-03 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01551316
The ClinicalTrials.gov registry entry for NCT01551316 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 19 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is MediciNova, which has 17 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01551316 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01551316 about?
NCT01551316 is a clinical study titled "Safety Study to Evaluate MN-221 in Chronic Obstructive Pulmonary Disease (COPD) Patients". In MediciNova's clinical development plan for MN-221, it was recognized that treatment of COPD exacerbations may necessitate more than one single i.v. infusion and that patients in this population may have more co-morbidities (and concomitant medications) than has been generally studied so far. Thus...
What is the current status of trial NCT01551316?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2012-03. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01551316?
The interventions under investigation include: Placebo (DRUG), MN-221 (DRUG).
Who is sponsoring clinical trial NCT01551316?
This trial is sponsored by MediciNova, which has 17 total clinical trials registered on ClinicalTrials.gov.
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