Staphylococcal InfectionPhase 1NCT01592214
Study of the Safety and Local Tolerability of Intranasal Gel Formulations of XF-73
A Phase 1 study testing XF-73 in 2% Klucel gel and XF-73 in 4% Klucel gel in people with Staphylococcal Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Staphylococcal Infection
- What is being tested?
- XF-73 in 2% Klucel gel and XF-73 in 4% Klucel gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2012to Aug 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Normal, healthy male or female subjects aged between 18 and 45 years inclusive.
- For Part 2 only: Normal healthy subjects confirmed to be persistent SA carriers (NOTE: Persistent SA carriage is defined by 3 separate, SA (Staphylococcus aureus) positive cultures from nasal swabs: the first taken at Pre-Screening no more than 12 weeks (84 days) prior to first dosing, a confirmatory swab taken at Screening at least 7 days after Pre-Screening and a final confirmation swab taken on Admission, a day before dosing and at least 7 days after screening. Subjects may be dosed with only two positive swabs while awaiting the result of the third swab obtained on Admission, but dosing will be discontinued in subjects whose Admission swab is found to be negative for SA.
- Subject must be healthy, in the opinion of the Investigator, as determined by medical history (MH), physical examination (PE), normal nasal examination, and vital signs (VS).
- Subject's 12-lead electrocardiogram (ECG) must be normal or abnormal not clinically significant as reported by the overreading cardiologist.
- Subject's clinical laboratory results at Screening must be within the reference range or expanded range.Subjects may undergo a repeat screening test of out-of-range analytes at the discretion of the investigator to confirm a plausible alternative explanation that will be indicated in the source documentation.
- Any subject having laboratory values outside of the reference range or expanded range at Day -1 but were within the reference or expended range at screening may be enrolled on study. Abnormal urine dipstick values for blood/hemoglobin, nitrite, and leukocyte esterase will not be exclusionary if a microscopic examination of the urine on the same sample or the most recent sample obtained prior to dosing is within the reference or expanded range. Laboratory values outside the reference or expanded range will be assigned to toxicity grade.
Show all 11Show fewer
- Subjects who are able and willing to provide written informed consent to participate in the study.
- Subject agrees to comply with all study requirements.
- All female subjects of childbearing potential must have a negative serum and urine pregnancy test at Screening and Admission respectively.
- Subjects who have a body mass index (BMI) >/= 18.5 kg/m^2 and </= 35 kg/m^2.
- Subject agrees not to participate in another clinical trial at any time during the study period.
Who cannot join
- Female subjects who are pregnant or who are lactating.
- Heterosexually active females of child-bearing potential, defined as being physiologically capable of becoming pregnant, unless they agree to use two of the following acceptable methods of contraception throughout their participation in the study and for at least 12 weeks after the final dose: (a) established use of oral, injected or implanted hormonal contraception, (b) intrauterine Device (IUD or Coil), (c) a female barrier method (diaphragm or cervical/vault cap) and/or (d) condom plus spermicidal cream/gel. Women who are not sexually active (abstinent) but become active must use two of the listed contraceptive methods.
- Heterosexually active males unless they agree to use two concomitant acceptable methods of contraception throughout their participation in the study and for at least 12 weeks after receiving their final dose of study medication (examples include: vasectomy combined with latex condom with spermicide, latex condom with spermicide combined with a female partner who practices an acceptable method of contraception as indicated above); Men who are not sexually active (abstinent) but become active must use two of the listed contraceptive methods. Subjects who currently have or have had any acute illness within the past two weeks.
- Subjects who currently have or have had within the past two weeks a poorly controlled chronic illness(anemia, thrombocytopenia, or coagulation disorders), cancer, infection, or any other clinically significant disorder.
- Subjects who currently have or have had an autoimmune disease.
- Subjects who have had within the past two weeks a symptomatic upper respiratory tract infection, nasopharyngitis, influenza or condition involving increase in nasal secretion such as seasonal or chronic, allergic rhinitis. Additionally, any subject with history of atopy/allergies within the past 30 days will be excluded.
Show all 27Show fewer
- Subjects who have had been diagnosed with a concussion within the past two years.
- Subjects with a history of serious psychiatric condition (depression, bipolar disorder, schizophrenia, suicidal ideation, or suicide attempts) or receiving two concomitant medications for the treatment of a psychiatric disorder or hospitalized for the treatment of a serious psychiatric disorder within six months of participation in the study.
- Subjects with known skin photosensitivity.
- Subjects with a personal or family history of porphyria.
- Subjects with any open wound, lesion, inflammation, erythema, or infection affecting the nostrils, nose, upper lip, and area of skin close to the nose, including herpes simplex lesions and discoid lupus.
- Subjects with a history of abnormal bleeding, bruising, frequent nosebleeds, or the diagnosis of von Willebrand disease.
- Subjects with nasal polyps or significant anatomical nasal abnormality. Patients with deviated septa will be allowed in the study, provided the principal investigator does not deem a deviation to be of significant medical consequence. An ENT(Ear, Nose and Throat) specialist will be available for consult as needed.
- Subjects with a history of nasal surgery, including cauterization, in the last 6 months.
- Subjects with a history of multiple episodes [>3] of epistaxis within the 12 months prior to screening.
- Subjects with in situ nasal jewelry or open nasal piercings.
- Subjects with a known clinically significant history of atopy or hypersensitivity to any drug or latex or to ingredients of the nasal gel (such as benzalkonium chloride or other quaternary ammonium disinfectants) or to drugs related to XF-73.
- Subjects known to have dermal sensitivity to chlorhexidine gluconate (CHG).
- Subjects who have smoked within the month prior to screening.
- Subjects who have been treated with or have taken any prescribed or over-the-counter medication daily for the last 14 days, with the exception of hormonal contraceptives or hormone replacement therapy.
- Subjects who have taken or used topical or systemic antibiotics within the month prior to screening.
- Subjects who have received an immunization within 30 days prior to screening.
- Subjects with a history of drug or alcohol abuse in the last 12 months or who have a positive urine drug test for substances of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine metabolites, opiates, phencyclidine [PCP]) or alcohol.
- Subjects who are known to have serum hepatitis, or who are carriers of the hepatitis B surface antigen(HBsAg) or hepatitis C (HCV) antibody, or who have a positive result to the test for human immunodeficiency virus (HIV) antibodies.
- Subjects who have participated in a drug or vaccine clinical trial within the last month.
- Subjects who have been exposed to XF-73 as part of a previous clinical trial.
- Presence of any other condition or laboratory result that, in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Anaheim Clinical Trials - Phase I Clinical Pharmacology Unit
Anaheim, California, 92801-2417
Case Western Reserve University - Case Medical Center - Infectious Disease & HIV Medicine
Cleveland, Ohio, 44106-1716
About this study
Official title: A Two-Part Phase I Study to Establish and Compare the Safety and Local Tolerability of Two Nasal Formulations of XF-73 for Decolonization of Staphylococcus Aureus: A Previously Investigated 0.5 mg/g Viscosified Gel Formulation Versus a Modified 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. 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
Read the 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.
- Conditions
- Staphylococcal Infection
- Being tested
- Placebo, XF-73 in 2% Klucel gel, XF-73 in 4% Klucel gel
- Keywords
- Staphylococcus aureus, nasal decolonization, XF-73, gel formulation
- Medical subject headings
- Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
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 2% Klucel gelDrug
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 4% Klucel gelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: XF-73 in 2% Klucel gel |
| 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. Receives: Other: Placebo |
| 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. Receives: Drug: XF-73 in 4% Klucel gel |
| 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. Receives: Drug: XF-73 in 2% Klucel gel |
| 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. Receives: Drug: XF-73 in 2% Klucel gel |
| 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. Receives: Drug: XF-73 in 2% Klucel gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The local (nasal and nasal passage) and systemic safety and tolerability of XF-73 following nasal administration in healthy male and female subjects
Measured: Day 1 through Day 8 (Part 1) and Day 1 through Day 14 (Part 2)
Secondary outcomes (3)
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
Measured: 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).
Measured: 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).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startAug 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Staphylococcal InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01592214
- Sponsor's protocol ID
- 11-0007
- Other IDs
- HHSN272201500007I, XF-73
- Status last verified
- Jul 2016
- First submitted
- 3 May 2012
- Last updated
- 5 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two-Part Phase I Study to Establish and Compare the Safety and Local Tolerability of Two Nasal Formulations of XF-73 for Decolonization of Staphylococcus Aureus: A Previously Investigated 0.5 mg/g Viscosified Gel Formulation Versus a Modified Formulation
- ClinicalTrials.gov ID
- NCT01592214
- Acronym / sponsor ID
- 11-0007
- Conditions
- Staphylococcal Infection
- Keywords
- Staphylococcus aureus, nasal decolonization, XF-73, gel formulation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Aug 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 7 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part 1 #2-XF-73 in 2% Klucel® gel, concentration 2.0 mg/g | Experimental | Drug: XF-73 in 2% Klucel gel4 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. |
| Part 2 #4-Placebo in 4% Klucel® gel, concentration 0 mg/g | Placebo comparator | Other: Placebo12 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. |
| Part 2 # 3-XF-73 in 4% Klucel® gel, concentration 0.5 mg/g: | Active comparator | Drug: XF-73 in 4% Klucel gel12 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. |
| Part 2 #2- XF-73 in 2% Klucel® gel, concentration 2.0 mg/g | Experimental | Drug: XF-73 in 2% Klucel gel12 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. |
| Part 2 #1- XF-73 in 2 % Klucel® gel, concentration 0.5 mg/g | Experimental | Drug: XF-73 in 2% Klucel gel12 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. |
| Part 1 #1-XF-73 in 2% Klucel® gel, concentration 0.5 mg/g: | Experimental | Drug: XF-73 in 2% Klucel gel4 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Normal, healthy male or female subjects aged between 18 and 45 years inclusive.
- For Part 2 only: Normal healthy subjects confirmed to be persistent SA carriers (NOTE: Persistent SA carriage is defined by 3 separate, SA (Staphylococcus aureus) positive cultures from nasal swabs: the first taken at Pre-Screening no more than 12 weeks (84 days) prior to first dosing, a confirmatory swab taken at Screening at least 7 days after Pre-Screening and a final confirmation swab taken on Admission, a day before dosing and at least 7 days after screening. Subjects may be dosed with only two positive swabs while awaiting the result of the third swab obtained on Admission, but dosing will be discontinued in subjects whose Admission swab is found to be negative for SA.
- Subject must be healthy, in the opinion of the Investigator, as determined by medical history (MH), physical examination (PE), normal nasal examination, and vital signs (VS).
- Subject's 12-lead electrocardiogram (ECG) must be normal or abnormal not clinically significant as reported by the overreading cardiologist.
- Subject's clinical laboratory results at Screening must be within the reference range or expanded range.Subjects may undergo a repeat screening test of out-of-range analytes at the discretion of the investigator to confirm a plausible alternative explanation that will be indicated in the source documentation.
Key exclusion criteria (27 listed)
- Female subjects who are pregnant or who are lactating.
- Heterosexually active females of child-bearing potential, defined as being physiologically capable of becoming pregnant, unless they agree to use two of the following acceptable methods of contraception throughout their participation in the study and for at least 12 weeks after the final dose: (a) established use of oral, injected or implanted hormonal contraception, (b) intrauterine Device (IUD or Coil), (c) a female barrier method (diaphragm or cervical/vault cap) and/or (d) condom plus spermicidal cream/gel. Women who are not sexually active (abstinent) but become active must use two of the listed contraceptive methods.
- Heterosexually active males unless they agree to use two concomitant acceptable methods of contraception throughout their participation in the study and for at least 12 weeks after receiving their final dose of study medication (examples include: vasectomy combined with latex condom with spermicide, latex condom with spermicide combined with a female partner who practices an acceptable method of contraception as indicated above); Men who are not sexually active (abstinent) but become active must use two of the listed contraceptive methods. Subjects who currently have or have had any acute illness within the past two weeks.
- Subjects who currently have or have had within the past two weeks a poorly controlled chronic illness(anemia, thrombocytopenia, or coagulation disorders), cancer, infection, or any other clinically significant disorder.
- Subjects who currently have or have had an autoimmune disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo: 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. | Other | Part 2 #4-Placebo in 4% Klucel® gel, concentration 0 mg/g |
| XF-73 in 2% Klucel gelXF-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. | Drug | Part 1 #1-XF-73 in 2% Klucel® gel, concentration 0.5 mg/g:, Part 1 #2-XF-73 in 2% Klucel® gel, concentration 2.0 mg/g, Part 2 #1- XF-73 in 2 % Klucel® gel, concentration 0.5 mg/g, Part 2 #2- XF-73 in 2% Klucel® gel, concentration 2.0 mg/g |
| XF-73 in 4% Klucel gelXF-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. | Drug | Part 2 # 3-XF-73 in 4% Klucel® gel, concentration 0.5 mg/g: |
Primary outcome
The local (nasal and nasal passage) and systemic safety and tolerability of XF-73 following nasal administration in healthy male and female subjects
Time frame: Day 1 through Day 8 (Part 1) and Day 1 through Day 14 (Part 2)
3 secondary outcomes
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
Time frame: 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).
Time frame: 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).
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2016.
Related trials for Staphylococcal Infection
RecruitingObservational study
Modeling Host-Pathogen Interaction Using Lymphoid Organoids
Staphylococcal Infections
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin-Resistant Staphylococcus Aureus Colonization
RecruitingPhase 2
Combination Cefazolin With Ertapenem for Methicillin-susceptible Staphylococcus Aureus Bacteremia
Staphylococcus Aureus Bacteremia, Staphylococcus Aureus Septicemia
Active, not recruitingPhase 1/2
A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
Staphylococcus Aureus
Not yet recruiting
Bacterial Decolonization to Prevent Severe Radiation Dermatitis in Head and Neck Squamous Cell Carcinoma
HNSCC
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XF-73 in 2% Klucel gel and XF-73 in 4% Klucel gel in people with Staphylococcal Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The local (nasal and nasal passage) and systemic safety and tolerability of XF-73 following nasal administration in healthy male and female subjects (time frame: Day 1 through Day 8 (Part 1) and Day 1 through Day 14 (Part 2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2016.