A Phase Ib, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 After Single and Repeated Ascending Doses in Patients Affected by Cystic Fibrosis and Non Cystic Fibrosis Bronchiectasis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Adverse event
研究概览
简要总结
CHF 6333 is a medicinal product on development for the treatment of cystic fibrosis and non-CF bronchiectasis and undergoing clinical testing. It has not yet been approved by the authorities for the treatment of these diseases.
CHF6333 is an inhaled anti-inflammatory which mechanism of action is based on the inhibition of Human Neutrofil Elastase.
The safety and tolerability of single and repeated ascending doses of inhaled CHF 6333 was previously investigated in healthy subjects: information was gathered on the uptake, distribution and excretion of the medicinal product being tested (pharmacokinetics). In this current clinical trial CHF 6333 will be tested in patients(CF and NCFB) for the first time.
Three dose level will be tested during the first part of the study, as single administration. One repeated dose will be administered in the second part of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
CHF6333
CHF6333 Active (part I - SAD). Once daily inhaled single dose of CHF6333 at each period (three dose level).
CHF6333 Active (part II -MD). Once daily inhaled multiple dose of CHF6333 for 7 consecutive days.
干预措施: CHF 6333 (Drug)
CHF6333 Placebo
Part I (SAD): Single dose of placebo matching CHF6333 at each period
Part II (MD): Once daily multiple doses of placebo matching CHF6333 for 7 consecutive days
干预措施: Placebo (Drug)
结局指标
主要结局
Adverse event
时间窗: Part I: Baseline through end of treatment (up to a maximum of 30 days after last study drug intake) ; Part II Baseline through end of treatment (up to a maximum of 30 days after last study drug intake)
Occurrence and severity of adverse events
Change in Vital signs
时间窗: Part I: Day 1 pre-dose up to 6 hours post dose. Part II: Day 1 and Day 7 pre dose up to 6 hours post dose
Change in Systolic and Diastolic blood pressure
Heart Rate
时间窗: Part I: Day 1 pre dose up to 8 hours post dose. Part II: Day 1 and Day 7 pre dose up to 12 hours post dose
Change in Heart Rate
PR interval
时间窗: Part I: Day 1 pre dose up to 8 hours post dose. Part II: Day 1 and Day 7 pre dose up to 12 hours post dose
Change in PR interval
QRS interval
时间窗: Part I: Day 1 pre dose up to 8 hours post dose. Part II: Day 1 and Day 7 pre dose up to 12 hours post dose
Change in QRS interval
QTCf interval
时间窗: Part I: Day 1 pre dose up to 8 hours post dose. Part II: Day 1 and Day 7 pre dose up to 12 hours post dose
Change in QTCf interval
FEV1
时间窗: Part I: Day 1 pre dose up to 6 hours post dose. Part II: Day 1 and Day 7 pre dose up to 6 hours post dose. Day 2 -6: pre dose up to 2 hours post dose
Change in FEV1
次要结局
- Rac(Part II: Day 7)
- AUC(Part I: Day 1. Part II Day 1-7)
- Cmax(Part I: Day 1. Part II Day 1-7)
- T max(Part I: Day 1. Part II Day 1-7)
- C24h(Part II: Day 5 Day 6)
- NE activity(Part I: Day -1 Day 1. Part II: Day -1 - 7)