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NCT02723539 · ClinicalTrials.gov registry record · Phase 1
A Trial to Assess Safety and Efficacy of Topical MBN-101 in Patients With Moderate/ Severe DFI
A Phase 1 study, sponsored by Microbion Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT02723539 is a Phase 1 study that has completed, run by Microbion Corporation. The registered enrollment target is 52 participants.
The verdict
NCT02723539, a Phase 1 study, has completed, sponsored by Microbion Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
This is a randomized, double-blind, placebo-controlled, multi-center study, in patients with moderate to severe diabetic foot infection (DFI), that will be conducted in two parts. In Part I, patients will be enrolled into 1 of 3 escalating dose cohorts at a ratio of 3:1 (Active to Placebo). In Part II, patients will be randomized in a 1:1 ratio (Active to Placebo) based on the optimal dose demonstrated in Part I. Patients will be randomized to receive either topical application of MBN-101 or topical application of vehicle, applied directly to the target site, 3 times per week, for a minimum of 14 days and up to a maximum of 21 days. All patients will also receive systemic antibiotic treatment.
Interventions
- DRUG Placebo
- DRUG MBN-101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2017-03-06 |
| Est. Completion | 2019-07-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02723539
The ClinicalTrials.gov registry entry for NCT02723539 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Microbion Corporation, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02723539 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02723539 about?
NCT02723539 is a clinical study titled "A Trial to Assess Safety and Efficacy of Topical MBN-101 in Patients With Moderate/ Severe DFI". This is a randomized, double-blind, placebo-controlled, multi-center study, in patients with moderate to severe diabetic foot infection (DFI), that will be conducted in two parts. In Part I, patients will be enrolled into 1 of 3 escalating dose cohorts at a ratio of 3:1 (Active to Placebo). In Part ...
What is the current status of trial NCT02723539?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2017-03-06. Estimated completion is 2019-07-26.
What interventions are being tested in trial NCT02723539?
The interventions under investigation include: Placebo (DRUG), MBN-101 (DRUG).
Who is sponsoring clinical trial NCT02723539?
This trial is sponsored by Microbion Corporation, which has 3 total clinical trials registered on ClinicalTrials.gov.
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