A Randomised, Double-blind, Placebo-controlled, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of VR942 in Healthy Subjects and Repeated Doses in Mild Asthmatics
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Number of participants with adverse events as a measure of the safety and tolerability of single doses of VR942 in healthy subjects and repeated doses of VR942 in mild asthmatics
研究概览
简要总结
The purpose of the study is to Evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of single inhaled doses of VR942 in healthy subjects (part 1) and repeated doses in mild asthmatics (part 2).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 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
VR942 Dose 2
VR942 Dose 2
干预措施: VR942 delivered via a Vectura Dry Powder Inhaler (Drug)
VR942 Dose 1
VR942 Dose 1
干预措施: VR942 delivered via a Vectura Dry Powder Inhaler (Drug)
VR942 Dose 1
VR942 Dose 1
干预措施: Placebo delivered via a Vectura Dry Powder Inhaler (Drug)
VR942 Dose 2
VR942 Dose 2
干预措施: Placebo delivered via a Vectura Dry Powder Inhaler (Drug)
VR942 Dose 3
VR942 Dose 3
干预措施: VR942 delivered via a Vectura Dry Powder Inhaler (Drug)
VR942 Dose 3
VR942 Dose 3
干预措施: Placebo delivered via a Vectura Dry Powder Inhaler (Drug)
VR942 Dose 4
VR942 Dose 4
干预措施: VR942 delivered via a Vectura Dry Powder Inhaler (Drug)
VR942 Dose 4
VR942 Dose 4
干预措施: Placebo delivered via a Vectura Dry Powder Inhaler (Drug)
VR942 Dose 5
VR942 Dose 5
干预措施: VR942 delivered via a Vectura Dry Powder Inhaler (Drug)
VR942 Dose 5
VR942 Dose 5
干预措施: Placebo delivered via a Vectura Dry Powder Inhaler (Drug)
结局指标
主要结局
Number of participants with adverse events as a measure of the safety and tolerability of single doses of VR942 in healthy subjects and repeated doses of VR942 in mild asthmatics
时间窗: 28 days
o Vital signs, physical examinations, any AEs or adverse device effects, laboratory tests, spirometry, and ECG variables
次要结局
- The pharmacodynamics of repeat doses of VR942 in mild asthmatics(28 days)
- The pharmacokinetic profile of single (Part 1) and repeated doses (part 2) of VR942 (time frame 4 and 14 days for Part 1 & 2 respectively):(4 and 14 days for Part 1 and 2 respectively)
- The number of used blisters and inhalers that do not meet the performance characteristics of the device intended by the manufacturer(28 days)