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NCT01592214 · ClinicalTrials.gov registry record · Phase 1
Study of the Safety and Local Tolerability of Intranasal Gel Formulations of XF-73
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 48
- Enrollment target
NCT01592214 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 48 participants.
The verdict
NCT01592214, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This is a Phase I, multi-center, clinical study of XF-73 to evaluate the local (nasal) safety and tolerability of a modified, thinner lower viscosity formulation of intranasal XF-73 in healthy male and female subjects. In addition, the potential for systemic absorption of XF-73 in the modified, thinner lower viscosity and the previously investigated thicker, higher viscosity formulations and their decolonization efficacy in comparison to placebo will be evaluated. Both parts of the study will be double-blinded and Part 2 will also be placebo-controlled. Primary objective is to establish the safety and tolerability of two concentrations of a modified thinner, lower viscosity nasal formulation of XF-73 and to compare them to a previously investigated, thicker, higher viscosity formulation
Interventions
- OTHER Placebo
- DRUG XF-73 in 2% Klucel gel
- DRUG XF-73 in 4% Klucel gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-08 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01592214
The ClinicalTrials.gov registry entry for NCT01592214 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01592214 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01592214 about?
NCT01592214 is a clinical study titled "Study of the Safety and Local Tolerability of Intranasal Gel Formulations of XF-73". This is a Phase I, multi-center, clinical study of XF-73 to evaluate the local (nasal) safety and tolerability of a modified, thinner lower viscosity formulation of intranasal XF-73 in healthy male and female subjects. In addition, the potential for systemic absorption of XF-73 in the modified, thin...
What is the current status of trial NCT01592214?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2012-08. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01592214?
The interventions under investigation include: Placebo (OTHER), XF-73 in 2% Klucel gel (DRUG), XF-73 in 4% Klucel gel (DRUG).
Who is sponsoring clinical trial NCT01592214?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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