A Randomised, Double-Blind, Vehicle-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of Two Dosage Forms of BTX 1801 Applied Twice Daily for Five Days to the Anterior Nares of Healthy Adults Nasally Colonised with Staphylococcus aureus
Botanix Pharmaceuticals Ltd
60 participants
Aug 24, 2020
Interventional
Conditions
Summary
The purpose of this study is to demonstrate the effectiveness of BTX 1801 presented as two different dosage forms to eradicate carriage of Staph. aureus on Day 12 in the anterior nares of individuals who are persistent carriers of Staph. aureus. The study will look to see whether there is a difference in the percent of anterior nares culture that are negative for Staph. aureus at Day 12 between active BTX 1801 formulations and the combined Vehicle formulations applied twice daily for 5 days.
Eligibility
Inclusion Criteria8
- Participant is of either gender of 18 – 65 years of age.
- Participant is in good general health, as determined by the investigator.
- Confirmed to be nasal Staph. aureus carriers, defined as having two separate Staph. aureus positive cultures from anterior nares swabs during the screening period.
- Participant agrees to not use marijuana or cannabidiol products throughout the study.
- Male participants and their partners must commit to use contraception throughout the study and for 90 days after last study drug application.
- A negative urine pregnancy test result for all women of child-bearing potential at the Baseline Visit.
- Sexually active women must agree to use contraception throughout the study and for 30 days after last study drug application.
- Male participants must refrain from sperm donation during the course of the study and until 90 days post study drug administration.
Exclusion Criteria21
- Female participant who is breastfeeding, pregnant, or planning to become pregnant.
- Methicillin-susceptible and methicillin-resistant Staphylococcus aureus decolonisation attempt in the 6 months prior to screening.
- Unable to tolerate nasal application of study product.
- Nasal surgery within 3 months prior to the Screening Visit 1.
- Evidence of active rhinitis, sinusitis or upper respiratory tract infection at Screening Visits 1 or 2 or Baseline Visit.
- Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study drug.
- Participant has used any marijuana products, via any route, within 4 weeks prior to the Screening Visit 1.
- Participant has any significant active infection.
- Participant has known human immunodeficiency viruses (HIV) infection or hepatitis B or C.
- Participant has used topical or systemic antibiotics within 4 weeks of Screening 1 Visit..
- Participant is using or plans to use a clinically significant concomitant/prohibited drug therapy, treatment or procedure.
- Participant has clinically significant or severe allergies that in the investigator’s opinion would interfere with participation in the study.
- Participant has used systemic or other immunosuppressive medications within 4 weeks of the Screening 1 Visit. Visit (inhaled corticosteroid less than 1000 µg daily dose is acceptable).
- Participant has a clinically relevant history or currently suffering from any disease or condition that, in the opinion of the investigator, may affect the evaluation of the study drug or place the participant at undue risk.
- Participant has a clinically relevant history of or current evidence of abuse of alcohol or other drugs.
- Participant has participated in another investigational drug or device research study within 30 days of the Screening Visit or five half-lives of the drug, whichever is longer.
- Negative nasal culture for Staph. aureus at Screening Visit 1 or 2.
- Planned use of any nasal applied medication (other than the study drug) during the study.
- Participant has suspected or known (previous or current) COVID-19 infection.
- People who would otherwise qualify for the study but are employees of the study site or living in the same household as an employee.
- People living in the same household as an active participant of the study
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Interventions
BTX 1801 20% (w/w) Ointment or BTX 1801 20% (w/w) Gel. 250 mg of study drug applied twice daily using participant's finger-tip to the anterior nares for 5 days. Treatment is assigned via randomization code. All patients will be required to maintain a diary documenting each application of study drug. Patients will return the study drug tube at each visit so that the clinical site staff can ensure patient compliance with dosing.
Locations(1)
View Full Details on ANZCTR
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ACTRN12620000456954