Ann: Phase 2a Study Shows BTX 1801 Eradicates S. Aureus, page-228

Excerpt from the study design submission for BTX 1801 phase 2a study to the Australian and New Zealand Clinical Trial Registry:

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.