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Trial registered on ANZCTR


Registration number
ACTRN12620000456954
Ethics application status
Approved
Date submitted
20/03/2020
Date registered
8/04/2020
Date last updated
8/04/2020
Date data sharing statement initially provided
8/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 300812 0
BTX.1801.111
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Staphylococcus aureus infection 316692 0
Condition category
Condition code
Infection 314937 314937 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317139 0
Treatment: Drugs
Comparator / control treatment
BTX 1801 Vehicle Ointment or BTX 1801 Vehicle Gel.
Control group
Placebo

Outcomes
Primary outcome [1] 323249 0
Evaluate the safety and tolerability of two dosage forms of BTX 1801 20% (w/w) when applied twice daily to the anterior nares of healthy adults nasally colonised with Staph. aureus.
Outcome assessed by monitoring treatment-emergent adverse events (TEAEs), local tolerability (Total Nasal Symptom Score and macroscopic nasal examination), clinical laboratory assessments, physical examination, and vital signs.
Examples of known/possible adverse reactions/events include eye irritation, unfavorable symptom at the application site, and skin reactions which may include redness, dryness, itchiness, scaling, and burning/stinging.
Timepoint [1] 323249 0
TEAEs reviewed daily from Baseline to Day 5 and at Days 8, 12 and 28.
Total Nasal Symptom Score measured daily from Baseline to Day 5 and at Day 8.
Macroscopic nasal examination performed daily from Baseline to Day 5 and at Days 8, 12 and 28.
Clinical laboratory assessments performed at Baseline and at Day 8.
Physical examination performed at Baseline and at Day 8.
Vital signs performed at Baseline and at Day 8.
Primary outcome [2] 323250 0
Demonstrate the effectiveness of BTX 1801 presented as two different dosage forms to eradicate carriage of Staph. aureus by assessing the percentage of persistent carriers with a negative nasal culture.
Timepoint [2] 323250 0
At Day 12
Secondary outcome [1] 381384 0
Explore the rates of Staph. aureus nasal recolonization in participants with negative nasal culture.
Timepoint [1] 381384 0
At Day 8, at Day 12 and/or at Day 28.
Secondary outcome [2] 381385 0
Evaluate the effect of BTX 1801 presented as two different dosage forms to eradicate carriage of Staph. aureus when applied twice daily for 5 days to the anterior nares by assessing the percentage of persistent Staph. aureus carriers with a negative nasal culture.
Timepoint [2] 381385 0
At Day 8 and at Day 28.
Secondary outcome [3] 381386 0
Evaluate the effect of BTX 1801 presented as two different dosage forms on nasal carriage of methicillin-resistant Staph. aureus (MRSA) when applied twice daily for 5 days to the anterior nares by assessing the percentage of participants with a negative nasal culture.
Timepoint [3] 381386 0
At Day 8, at Day 12 and at Day 28.
Secondary outcome [4] 381387 0
Evaluate the pre-dose blood levels of CBD following application of two different dosage forms of BTX 1801 twice daily for 5 days to the anterior nares.
Timepoint [4] 381387 0
At Day 2 and at Day 5.

Eligibility
Key inclusion criteria
1. Participant is of either gender of 18 – 65 years of age.
2. Participant is in good general health, as determined by the investigator.
3. Confirmed to be nasal Staph. aureus carriers, defined as having two separate Staph. aureus positive cultures from anterior nares swabs during the screening period.
4. Participant agrees to not use marijuana or cannabidiol products throughout the study.
5. Male participants and their partners must commit to use contraception throughout the study and for 90 days after last study drug application.
6. A negative urine pregnancy test result for all women of child-bearing potential at the Baseline Visit.
7. Sexually active women must agree to use contraception throughout the study and for 30 days after last study drug application.
8. Male participants must refrain from sperm donation during the course of the study and until 90 days post study drug administration.
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Female participant who is breastfeeding, pregnant, or planning to become pregnant.
2. Methicillin-susceptible and methicillin-resistant Staphylococcus aureus decolonisation attempt in the 6 months prior to screening.
3. Unable to tolerate nasal application of study product.
4. Nasal surgery within 3 months prior to the Screening Visit 1.
5. Evidence of active rhinitis, sinusitis or upper respiratory tract infection at Screening Visits 1 or 2 or Baseline Visit.
6. Any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study drug.
7. Participant has used any marijuana products, via any route, within 4 weeks prior to the Screening Visit 1.
8. Participant has any significant active infection.
9. Participant has known human immunodeficiency viruses (HIV) infection or hepatitis B or C.
10. Participant has used topical or systemic antibiotics within 4 weeks of Baseline.
11. Participant is using or plans to use a clinically significant concomitant/prohibited drug therapy, treatment or procedure.
12. Participant has clinically significant or severe allergies that in the investigator’s opinion would interfere with participation in the study.
13. Participant has used systemic or other immunosuppressive medications within 4 weeks of the Baseline Visit (inhaled corticosteroid less than 1000 µg daily dose is acceptable).
14. 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.
15. Participant has a clinically relevant history of or current evidence of abuse of alcohol or other drugs.
16. 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.
17. Negative nasal culture for Staph. aureus at Screening Visit 1 or 2.
18. Planned use of any nasal applied medication (other than the study drug) during the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered kits
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The selected sample size of approximately 60 participants is considered adequate to provide information on the effects of BTX 1801 on nasal Staph. aureus colonisation, as well as adequate safety and tolerability information.
The sample size is based on having appropriate sensitivity to observe a safety signal and adequately assess efficacy. No prospective calculations of statistical power were made for this exploratory study.
All participants who complete 5 days of dosing and the follow up visits and provide evaluable culture results will be included in the efficacy analyses. The Efficacy Population will be used to evaluate the effectiveness of the two different dosage forms of BTX 1801 for the nasal eradication of Staph. aureus.
All participants who receive at least one confirmed dose of study drug and have at least one Post-Baseline assessment will be included in the safety analyses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 16151 0
Captain Stirling Medical Centre - Nedlands
Recruitment postcode(s) [1] 29680 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 305268 0
Commercial sector/Industry
Name [1] 305268 0
Botanix Pharmaceuticals Ltd
Address [1] 305268 0
Level 1, 50 Angove Street, North Perth, Western Australia 6005
Country [1] 305268 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Botanix Pharmaceuticals Ltd
Address
Level 1, 50 Angove Street, North Perth, Western Australia 6005
Country
Australia
Secondary sponsor category [1] 305651 0
None
Name [1] 305651 0
Address [1] 305651 0
Country [1] 305651 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305613 0
Bellberry HREC
Ethics committee address [1] 305613 0
123 Glen Osmond Road, Eastwood, South Australia, 5063
Ethics committee country [1] 305613 0
Australia
Date submitted for ethics approval [1] 305613 0
24/12/2019
Approval date [1] 305613 0
25/02/2020
Ethics approval number [1] 305613 0
2019-12-1150-AA

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100958 0
Dr Michael Benson
Address 100958 0
Captain Stirling Medical Centre,
92 Stirling Highway,
Nedlands,
WA 6009
Country 100958 0
Australia
Phone 100958 0
+61 8 9386 1858
Fax 100958 0
Email 100958 0
donnabenson@iinet.net.au
Contact person for public queries
Name 100959 0
Dr Michael Thurn
Address 100959 0
Botanix Pharmaceuticals Ltd,
Level 1, 50 Angove Street,
North Perth,
WA 6005
Country 100959 0
Australia
Phone 100959 0
+61 403 192 615
Fax 100959 0
Email 100959 0
mthurn@botanixpharma.com
Contact person for scientific queries
Name 100960 0
Dr Michael Thurn
Address 100960 0
Botanix Pharmaceuticals Ltd,
Level 1, 50 Angove Street,
North Perth,
WA 6005
Country 100960 0
Australia
Phone 100960 0
+61 403 192 615
Fax 100960 0
Email 100960 0
mthurn@botanixpharma.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results