NCT01347190已完成1 期
A Double Blind, Randomized, Placebo Controlled, Single Dose, Phase I Study of the Safety and Tolerability of Alpha1 Proteinase Inhibitor (Human) Inhalation Solution (CR002) in Subjects With Cystic Fibrosis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 25
- 试验地点
- 11
- 主要终点
- Frequency of Adverse events
研究概览
简要总结
Study to assess safety and tolerability of a single dose of study-drug administered to Cystic Fibrosis (CF) patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a confirmed diagnosis of CF: one or more clinical findings consistent with CF and at least one of the following:
- •Sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test OR
- •A genotype with two identifiable mutations consistent with CF (∆F508 homozygous or two alleles known to cause a class I, II, or III mutation)
- •Have an FEV1 ≥30% of predicted normal as defined by age, gender, and height
排除标准
- •Oxygen saturation <90%
- •Changed in treatment regimen within 2 weeks prior to screening
- •Antibiotics regimen change < 4 weeks before screening
- •Persistent colonization with Burkholderia cepacia
- •Serum IgA < 50% of lower level of normal
结局指标
主要结局
Frequency of Adverse events
时间窗: 44 Days (Day -21 to Day 22)
次要结局
未报告次要终点
研究者
研究点 (11)
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