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| ID | Type | Description | Link |
|---|---|---|---|
| HHSN272201500007I | |||
| XF-73 |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 #2-XF-73 in 2% Klucel® gel, concentration 2.0 mg/g | Experimental | 4 subjects: 2.0 mg/g concentrations of a modified 2% Klucel® gel formulation of XF-73 intranasally to both nares twice in a single day in a volume of 0.3 mL/naris/dose and total daily dose of 2.4 mg. |
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| Part 2 #4-Placebo in 4% Klucel® gel, concentration 0 mg/g | Placebo Comparator | 12 subjects: a placebo in 4% Klucel® gel intranasally to both nares in a volume of 0.3 mL/naris/dose,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. |
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| Part 2 # 3-XF-73 in 4% Klucel® gel, concentration 0.5 mg/g: | Active Comparator | 12 subjects: a modified 4% Klucel® gel formulation of XF-73 intranasally to both nares in a 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. |
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| Part 2 #2- XF-73 in 2% Klucel® gel, concentration 2.0 mg/g | Experimental | 12 subjects; a modified 2% Klucel® gel formulation of XF-73 intranasally to both nares in a concentration of 2.0 mg/g and volume of 0.3 mL/naris/dose,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 3.6 mg on Day 1 and 2.4 mg on Days 2 to 5. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Other | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| The local (nasal and nasal passage) and systemic safety and tolerability of XF-73 following nasal administration in healthy male and female subjects | Day 1 through Day 8 (Part 1) and Day 1 through Day 14 (Part 2) |
| Measure | Description | Time Frame |
|---|---|---|
| In the Part 2 of the study, anti-staphylococcal activity will be investigated, activity will be assessed as the presence or absence of SA and by quantification of the level of colonization | Part 2: Enrollment, Day 1 through Day 6 and Day 14. | |
| The efficacy of the modified formulation of XF-73 and of the previous formulation on nasal load of S. aureus after daily treatment with XF-73 for five days as compared to placebo (in Part 2 of the study only). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anaheim Clinical Trials - Phase I Clinical Pharmacology Unit | Anaheim | California | 92801-2417 | United States | ||
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| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| Part 2 #1- XF-73 in 2 % Klucel® gel, concentration 0.5 mg/g | Experimental | 12 subjects: a modified 2% Klucel® gel formulation of XF-73 intranasally to both nares in a concentration of 0.5 mg/g and volume of 0.3 mL/naris/dose, 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. |
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| Part 1 #1-XF-73 in 2% Klucel® gel, concentration 0.5 mg/g: | Experimental | 4 subjects: 0.5 mg/g concentration of a modified 2% Klucel® gel formulation of XF-73 intranasally to both nares twice in a single day in a volume of 0.3 mL/naris/dose and total daily dose of 0.6 mg. |
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| XF-73 in 2% Klucel gel | Drug | 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. |
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| XF-73 in 4% Klucel gel | Drug | 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. |
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| Part 2: Enrollment, Day 1 through Day 6 and Day 14. |
| The pharmacokinetics (PK) of XF-73 following nasal administration of two concentrations of a modified formulation (in both parts of the study) and a single concentration of a previously investigated formulation (in Part 2 of the study). | Part 1: 0 hr, at 15, 30 min, 1, 2, 4, 8, 12 hr after each dose. Part 2 within 15 min before 1st dose, 30, 240, 480 min after 1st dose. Day 3: 30 min after 1st dose; Day 5: within 15 min before 1st dose, 30, 240 min after. |
| Case Western Reserve University - Case Medical Center - Infectious Disease & HIV Medicine |
| Cleveland |
| Ohio |
| 44106-1716 |
| United States |