ACTRN12620000456954已完成2 期
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
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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 Screening 1 Visit..
- •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 Screening 1 Visit. 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.
- •19. Participant has suspected or known (previous or current) COVID-19 infection.
- •20. People who would otherwise qualify for the study but are employees of the study site or living in the same household as an employee.
- •21. People living in the same household as an active participant of the study
研究者
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