A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 Multi-Phage Therapeutic in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 29
- 主要终点
- P. Aeruginosa Recovery in Sputum Following Multiple Doses of AP-PA02 Administered by Inhalation
研究概览
简要总结
A phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 administered in subjects with non-cystic fibrosis bronchiectasis and chronic pulmonary Pseudomonas aeruginosa infection.
详细描述
This study will be conducted in two cohorts running in parallel: Cohort A will evaluate the safety, tolerability, and efficacy of inhaled AP-PA02 in subjects who have not received an antipseudomonal inhaled antibiotic for a minimum of 3 months prior. Cohort B will evaluate the safety, tolerability, and efficacy of inhaled AP-PA02 in subjects who have received an antipseudomonal inhaled antibiotic for a minimum of 3 months prior. Subjects in both Cohorts A and B will be followed for approximately 4 weeks after last dose of study drug and evaluated for safety, tolerability, and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old
- •Body mass index (BMI) of ≥ 18 kg/m2
- •Evidence of bronchiectasis per CT
- •Evidence of chronic pulmonary Pseudomonas aeruginosa infection
- •Willing to undergo sputum induction procedures at designated study visits, and willing to provide expectorated sputum samples at all other timepoints (for subjects who are able to expectorate)
- •FEV1 ≥ 35% of predicted normal [per Global Lung Function Initiative (GLI) standards] at Screening
- •For Cohort A: have not received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to Visit 1
- •For Cohort B: have received chronic inhaled antipseudomonal antibiotics regimen for at least 3 months prior to Visit 1
排除标准
- •Abnormal vital signs at Screening
- •History of lung transplantation
- •History of cystic fibrosis
- •History of α1-antitrypsin deficiency
- •History of primary or acquired immunodeficiency syndromes
- •History of COPD
- •History of pulmonary malignancy or any other malignancy requiring treatment
- •History of prolonged QT syndrome
- •History of hemoptysis
- •Recent significant weight loss
- •Recent use of supplemental oxygen during the day while at rest
- •Recent use of cigarettes, cigars, or pipes, or used tobacco or other nicotine source by vaping
- •Recent changes in either the treatment regimen or initiation of treatment with: oral macrolides, hypertonic saline, mucolytics, bronchodilator medications, or oral corticosteroids
- •Currently receiving treatment for active infection at any site
- •Female pregnant of breastfeeding
研究组 & 干预措施
AP-PA02
Anti-pseudomonal bacteriophage
干预措施: AP-PA02 (Biological)
Placebo
Inactive isotonic solution
干预措施: Placebo (Other)
结局指标
主要结局
P. Aeruginosa Recovery in Sputum Following Multiple Doses of AP-PA02 Administered by Inhalation
时间窗: Day 17
Change from baseline in P. Aeruginosa density (colony forming units) as measured in induced sputum samples one week after end of treatment.
次要结局
未报告次要终点