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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: Completed Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01592214 record still lists
NCT01592214 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01592214 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01592214's enrollment target sits among peer trials
48 1025th of 2000 higher than 948 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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