Safety, Preliminary Pharmacokinetics and Bronchodilator Properties of V0162
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- To assess the local tolerability of V0162 in healthy male volunteers
研究概览
简要总结
Pulmonary administered anticholinergic agents have shown their importance in the chronic obstructive pulmonary disease (COPD) management to reduce morbidity, disability and mortality. To date, the recommended treatment of moderate to severe COPD patients consist in the combination of ß2 agonist and long acting antimuscarinic compounds. There is still a medical need in new product that could exhibit both anti-inflammatory and strong bronchodilation potency. V0162 is a compound with a potent anticholinergic activity.
Secondary PD properties of V0162 could enhance the efficacy of this antimuscarinic compound and could bring new option in the treatment of this life-threatening disease.
详细描述
This study has two parts. Part A will be conducted in 72 healthy volunteers. Part B will be conducted in 20 patients diagnosed with COPD.
Part A The primary objective of this part of the study is to assess the local tolerability of escalating doses of V0162 in male healthy volunteers.
Part B The primary objective of this part of the study is to assess the bronchodilator properties of V0162 at the maximal tolerated dose (determined in Part A) in COPD patients.
In addition, pharmacokinetics and vital sign including ECG will be determined.
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 65 Years（Adult, Older Adult）
- 性别
- Male
- 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
V0162
干预措施: Bronchodilatator (Drug)
Placebo
干预措施: Bronchodilatator (Drug)
结局指标
主要结局
To assess the local tolerability of V0162 in healthy male volunteers
时间窗: change from baseline in the local tolerability over 72 h after dosing
Monitoring of parameters of the pulmonary function: spirometry measurements. Assessment of respiratory system symptoms: using a 4-point scale and assessment of dyspnoea by VAS. Monitoring for the occurrence of AEs. Changes in physical examination: vital signs (blood pressure and pulse rate), holter-ECG and clinical laboratory tests (biochemistry, haematology, urinalysis).
次要结局
- To determine the PK parameters of V0162 in healthy male volunteers(0, 5, 15, 30, 45 min, 1, 2, 4, 8, 12, 24, 48 and 72 h after dosing)
- To assess the bronchodilator properties of V0162 in COPD(0, 30 min, 1, 1.5, 2, 3, 4, 6, 8, 14, 20, 24, 28 and 32 h after dosing)