Phase I, Single and Multi-dose, Placebo Controlled, Randomized, Dose-Escalation Study to Evaluate the Safety, Tolerability and PK Profile of MP-376 Using the PARI eFlow Nebulizer for 14 Days to CF Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 40
- 主要终点
- Safety and tolerability of MP-376 administered twice a day for 14 days
研究概览
简要总结
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to eradicate and been implicated as the major cause of morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung increases the local concentrations of antibiotic at the site of infection resulting in improved antimicrobial effects compared to systemic administration. Bacterial resistance to current aerosol antibiotic treatments indicate a need for improved therapies to treat CF patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to have antimicrobial effects on even the most resistant organisms and reduce the emergence of resistant bacteria.
详细描述
This trial will be a single-blind, placebo-controlled, dose escalating between cohorts, single and multi-dose, multi-center study to evaluate the safety, tolerability and pharmacokinetic profile of levofloxacin administered as MP-376 once, then twice daily for 14 days by the aerosol route to CF patients.
Study acquired from Horizon in 2024.
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
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 16 years of age
- •Confirmed Diagnosis of Cystic Fibrosis
- •Positive sputum culture for P. aeruginosa within the past 6 months
- •Patients are able to elicit an FEV1 >/= 40% of predicted value at screening
- •Clinically stable with no evidence of acute respiratory or lower respiratory infections within 28 days prior to dosing
- •Able to reproducibly perform spirometry measurements and be able to repeatedly produce sputum over several hours
排除标准
- •Use of any nebulized or systemic antibiotics within 4 weeks of starting study
- •History of hypersensitivity to fluoroquinolones or intolerance with aerosol medication
- •Uncontrolled diabetes or abnormal renal function
- •Tobacco use (smoking) in the last 30 days
研究组 & 干预措施
1
Inhaled Levofloxacin
干预措施: MP-376 (Levofloxacin solution for Inhalation) (Drug)
2
Placebo
干预措施: placebo (Drug)
结局指标
主要结局
Safety and tolerability of MP-376 administered twice a day for 14 days
时间窗: 14 days
次要结局
- Evaluate changes in the microbiology of CF sputum after 14 days of treatment with MP-376(14 days)
- Evaluate changes in FEV1 and FVC over 14 days of Treatment(14 days)
- PK Profile of single-dose vs multi-dose of MP-376(14 days)