NCT02386761已完成1 期
A Phase 1, Randomised Double-blind, Placebo-controlled STUDY of Single and Repeated Ascending doseS in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6001
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
- 48
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
A phase I randomised, double-blind, placebo-controlled study of single and repeated ascending doses in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of inhaled chf 6001.
详细描述
To assess the safety and tolerability of single and repeated ascending doses of CHF 6001 in healthy volunteers and to investigate the pharmacokinetic (PK) profile of CHF 6001 and its metabolites CHF 5956 and CHF 6095.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single Ascending Dose (SAD)
Experimental
- Dose 1 (SAD1): 6 inhalations of CHF 6001 400 µg giving a total dose of 2400 µg
- Dose 2 (SAD2): 10 inhalations of CHF 6001 400 µg giving a total dose of 4000 µg
- Dose 3 (SAD3): 12 inhalations of CHF 6001 400 µg giving a total dose of 4800 µg Placebo (P): the number of placebo inhalations will match that of the active CHF 6001 pertaining to the same dose period.
In case the actual doses are modified, the number of inhalations will be adapted accordingly.
干预措施: Single Ascending Dose (SAD) (Drug)
Multiple Ascending Dose (MAD)
Experimental
- Dose 1 (MAD1): Multiple doses of CHF 6001 - Total daily dose 2400 µg or placebo
- Dose 2 (MAD2): Multiple doses of CHF 6001 - Total daily dose 4000 µg or placebo
- Dose 3 (MAD3): Multiple doses of CHF 6001 - Total daily dose 4800 µg or placebo
Duration 14 days b.i.d.
干预措施: Multiple Ascending Dose (MAD) (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 0-14 days
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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