A Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Nebulized Bacteriophage Treatment in Outpatient Adult Cystic Fibrosis (CF) Subjects with Chronic Pseudomonas aeruginosa (PsA) Pulmonary Infection

BiomX Ltd.0 个研究点目标入组 32 人开始时间: 2023年4月19日最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•1. Cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infection receiving standard of care CF medications
•2. Age = 18 years
•3. FEV1 = 40% predicted
•4. Clinically stable lung disease
•5. Willing and able to provide adequate sputum samples, using any method (spontaneously expectorated, induced, from home or clinic) at designated study visits.
•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 32
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 32

•1. Known hypersensitivity to bacteriophages or excipients in the formulation.
•2. Receipt of prior bacteriophage therapy within the 6 months prior to Screening
•3. Recovery of Burkholderia species from respiratory tract within 1 year prior to screening
•4. Currently receiving treatment for allergic bronchopulmonary aspergillosis
•5. Currently receiving treatment for active infection with non-tuberculous mycobacteria
•6. History of severe neutropenia
•7. History of lung transplant
•8. History of solid organ transplant
•9. Acquired or primary immunodeficiency syndrome
•10. Initiation or change in CF modulator therapy less than 3 months prior to screening
•11. Pregnant or breastfeeding female

发起方