A Randomised, Double Blind, Placebo-controlled, Three Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treatment With Single and Repeat Doses of Inhaled RV1162 in Healthy Subjects and Subjects With Chronic Obstructive Pulmonary Disease.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 78
- 主要终点
- Incidence of treatment emergent adverse events
研究概览
简要总结
RV1162 is a new medicine being developed for possible treatment of smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD). The main purpose of this study is to investigate the safety, tolerability and pharmacokinetics of single and repeat doses of RV1162.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older 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
Part A: single dose escalation (healthy subjects)
干预措施: RV1162 single dose (Drug)
Part A: single dose escalation (healthy subjects)
干预措施: RV1162 matching placebo single dose (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events
时间窗: Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days,
Assessment of the number of adverse events reported by subject following dosing
ECG assessment (12-lead ECG)
时间窗: Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days
Change from pre-dose values
Vital sign assessment (blood pressure and heart rate)
时间窗: Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days
Change from pre-dose values
Spirometry assessment (FEV1 & FVC)
时间窗: Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days
Change from pre-dose values
Clinical laboratory assessments (blood and urine samples)
时间窗: Cohorts 1 & 2, 42 days: Cohort 3, 15 days: Cohort 4, 21 days: Cohorts 5 & 6, 28 days
Change from pre-dose values
次要结局
- Plasma RV1162 levels(Part A: Cohorts 1 & 2 x 4 treatment periods (TP), Cohort 3 x 1 TP (0, 10, 15 & 30 min, 1 ,2, 4, 6, 8, 10, 12 & 24h post-dose) each TP; Part B (Cohort 4): 34 samples up to 21 days post-dose; Part C (Cohorts 5 & 6): 46 samples up to 28 days post-dose)