Study of the Safety and Local Tolerability of Intranasal Gel Formulations of XF-73
Status:
Completed
Trial end date:
2015-08-01
Target enrollment:
Participant gender:
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
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)