EUCTR2018-000243-87-GB进行中（未招募）1 期
An open-label study to assess the safety, pharmacokinetics and pharmacodynamics of inhaled PC945 in adult Cystic Fibrosis (CF) patients with persistent pulmonary Aspergillus fumigatus infection.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Subject must be male or female, aged 18 years inclusive or older (at the time of consent).
- •2. Subject must be willing and able to adhere to the restrictions and prohibitions required by this protocol.
- •3. Each subject must sign an informed consent form (ICF) indicating that he or she understands the purpose and requirements of the study and that they are willing to participate.
- •4. A confirmed diagnosis of CF by standard criteria.
- •5. Subject is able to produce sputum.
- •6. A history of persistently positive A. fumigatus sputum cultures from at least 2 sputum samples in the last year, the most recent of which must have been within the last 6 months.
- •7. Subject must have a positive sputum fungal culture at screening with one or more colonies of A. fumigatus detected using a modified standard approach.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
排除标准
- •1. Any other disease or condition, which in the Investigator’s medical opinion would preclude the subject’s participation in a clinical trial.
- •2. Is taking inhaled amphotericin B or has taken it within 7 weeks of Day 1.
- •3. Is taking systemic steroid treatment or has taken it within 4 weeks of Day 1. Subjects considered to be stable on a systemic steroid dose of <15 mg for at least a month will not be excluded.
- •4. Is taking systemic antifungal treatment (intravenous, oral or inhaled) or has received antifungal therapy (intravenous, oral or inhaled) within 6 weeks of Day 1.
- •5. If female, the subject is pregnant (e.g., has a positive serum ß human chorionic gonadotropin (ß-hCG) at screening or a positive urinary pregnancy test pre-dose on Day 1), lactating or breast feeding.
- •6. Any respiratory exacerbation within 2 weeks of the start of the study.
- •7. Any upper respiratory tract infection or signs or symptoms thereof within 2 weeks prior to dosing.
- •8. Positive culture for Mycobacterium abscessus within 12 months before screening or between screening and baseline, or currently receiving treatment for Mycobacterium abscessus.
- •9. Has chronic, active hepatitis or a positive hepatitis B surface antigen or positive hepatitis C antibody result at screening.
- •10. Is taking antiretroviral protease inhibitor therapy.
- •11. Allergy to any of the active or inactive ingredients in the study medication.
- •12. History of drug (or other) allergy or intolerance that, in the opinion of the Investigator or Pulmocide Medical Monitor, would contraindicate their participation.
- •13. Clinically significant haemoptysis (>200 mL per episode) within 90 days before screening.
- •14. Subject is mentally or legally incapacitated.
- •15. Subject is employed or is a first-degree relative of anyone employed by Pulmocide, a participating clinical trial site, or any contract research organisation involved in the study.
- •16. Any other reason that the Investigator considers makes the subject unsuitable to participate.
研究者
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