A Multi-center, Placebo-controlled, Double Blind Multiple-ascending Dose Study in a Leapfrog Design to Investigate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of RO5024118 Following Repeated Inhalation in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 主要终点
- To investigate the safety and tolerability of multiple inhaled doses of R7103 as compared to placebo, and to define the Maximum Tolerated Dose (MTD) in target population
研究概览
简要总结
This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of RO5024118 following repeated inhalation in patients with moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD). Patients will be randomized to receive multiple inhaled doses of R7103, as compared with placebo. The target sample size is approximately 30 individuals.
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
- Double
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients 40-70 years of age, inclusive.
- •Body Mass Index 18-32 kg/m2, inclusive.
- •Female patients must be surgically sterile or post menopausal for the past year confirmed by a negative hormone panel. Male patients and their partners of childbearing potential must use two methods of contraception, one of which must be a barrier method for the duration of the study and for 7 days after last dose.
- •Diagnosis of moderate-to-severe COPD (GOLD Stage II-III).
排除标准
- •Current smoker or history of smoking in the last three months.
- •Use of continuous daily long term oxygen therapy or requirement for oxygen therapy during exercise.
- •History of cardiac conduction abnormalities or ventricular tachyarrhythmias.
- •Exacerbation of COPD within 8 weeks before first dosing.
研究组 & 干预措施
1
R7103 (dose 1) followed by placebo or placebo followed by R7103 (dose 1)
干预措施: R7103 (Drug)
2
R7103 (dose 2) followed by placebo or placebo followed by R7103 (dose 2)
干预措施: R7103 (Drug)
3
R7103 (dose 3) followed by placebo or placebo followed by R7103 (dose 3)
干预措施: R7103 (Drug)
4
R7103 (dose 4) followed by placebo or placebo followed by R7103 (dose 4)
干预措施: R7103 (Drug)
5
R7103 (dose 5) followed by placebo or placebo followed by R7103 (dose 5)
干预措施: R7103 (Drug)
6
R7103 (dose 6) followed by placebo or placebo followed by R7103 (dose 6)
干预措施: R7103 (Drug)
结局指标
主要结局
To investigate the safety and tolerability of multiple inhaled doses of R7103 as compared to placebo, and to define the Maximum Tolerated Dose (MTD) in target population
时间窗: 18 days per arm
次要结局
未报告次要终点