Study of the Safety and Local Tolerability of Intranasal Gel Formulations of XF-73
Condition: Staphylococcal Infection
MeSH terms: Staphylococcal Infections
Study type: Interventional
Phase: Phase 1

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
    

Detailed description: 
      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. Study subjects will be healthy volunteers, male or female, aged 18 - 45
      years. The study will be conducted in two distinct parts. In Part 1 of the study 8 healthy
      male and female subjects, aged 18 to 45 years, will be in two groups of four per formulation
      will have a study duration of up to 36 days. All subjects will receive intranasal
      applications of 5,15-bis-[4-(3-Trimethylammonio-propyloxy)-phenyl]-porphyrin dichloride
      (XF-73). In Part 2 only, subjects will also need to be confirmed as persistent nasal SA
      carriers (n = 48). (Persistent SA carriage is defined by 3 separate, SA positive cultures
      from nasal swabs: the first taken at Pre-Screening no more than 12 weeks (84 days).
      Administration will last five days, being three times a day on Day 1, then twice a day
      thereafter. 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. Secondary
      objectives are to establish whether there is any potential systemic exposure following
      administration of the two nasal formulations of XF-73 and to evaluate the anti-staphylococcal
      efficacy of two concentrations of a lower and one of a thicker, higher viscosity nasal
      formulation of XF-73.
    

Intervention name(s): Placebo; XF-73 in 2% Klucel gel; XF-73 in 4% Klucel gel
Intervention type(s): Other; Drug; Drug
Intervention description(s): Placebo: 4% Klucel® gel formulation, concentration 0, total daily volume 1.8 ml, 3 doses 8 hours apart on Day 1 and 1.2 ml, 2 doses 12 hrs apart on Days 2 to 5.; XF-73 in a modified 2% Klucel® gel formulation: Part 1, #1: concentration 0.5 mg/g, twice a day in volume 0.3 mL/naris/dose, total dose 0.6 mg; Part 1, #2: 2.0 mg/g concentration, twice a day in volume 0.3 mL/naris/dose, total dose 2.4 mg; Part 2, #1: Concentration 0.5 mg/g, 3 doses 8 hours apart on Day 1, total volume 1.8 ml, total dose 0.9 mg, 2 doses 12 hours apart on Days 2-5, total volume 1.2 ml and total dose 0.6 mg ; Part 2, #2: 2.0 mg/g, 3 doses 8 hours apart on Day 1, total volume 1.8 ml, total dose 3.6 mg, 2 doses 12 hours apart on Days 2-5,total volume 1.2 ml and total dose 2.4 mg.; XF-73 in a 4% Klucel® gel formulation: Part 2 #3: concentration of 0.5 mg/g and volume of 0.3 mL/naris/dose in 3 doses 8 hours apart on Day 1 and 2 doses, 12 hours apart on Days 2 to 5. Total daily volume of 1.8 ml on Day 1 and 1.2 ml on Days 2 to 5; and total daily dose of 0.9 mg on Day 1 and 0.6 mg on Days 2 to 5.
Intervention MeSH terms: Benzocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Staphylococcus aureus, nasal decolonization, XF-73, gel formulation