NCT03056989已完成1 期
A Phase 1, Single-Center, Open-Label Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events
研究概览
简要总结
Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of CF
- •FEV1 ≥ 40% predicted normal
- •Stable CF lung disease
- •Non-pregnant, non-lactating females
排除标准
- •Significant unstable co-morbidities within 28 days of screening as judged by the Investigator.
- •Has received an investigational drug within the past 30 days
研究组 & 干预措施
SPX-101 High Dose
Experimental
Inhalation Solution twice daily for 7 days.
干预措施: SPX-101 (Drug)
SPX-101 Low Dose
Experimental
Inhalation Solution twice daily for 7 days.
干预措施: SPX-101 (Drug)
SPX-101 Mid Dose
Experimental
Inhalation Solution twice daily for 7 days.
干预措施: SPX-101 (Drug)
结局指标
主要结局
Number of participants with adverse events
时间窗: Day 1 through Day 15
次要结局
- Change from baseline through Day 8 in clinical laboratory tests(Screening and Day 1 through Day 8)
- Relative change from baseline through Day 8 in percent predicted FEV1(Screening and Day 1 through Day 8)
研究者
研究点 (1)
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