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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: Completed Phase 1 study, sponsored by MediciNova.
NCT01551316 is a Phase 1 study that has completed, run by MediciNova. The registered enrollment target is 19 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The recording of AEs will start after the subject has signed the consent form and will end at the Hour 24 phone interview. Investigator(s) will monitor each subject closely for AEs and the Investigator will record all observed or volunteered AEs.
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 |
What the finished NCT01551316 record still lists
NCT01551316 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01551316 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01551316's enrollment target sits among peer trials
19 1716th of 2000 higher than 281 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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