A Randomised, Placebo-Controlled, Double-Blind, Parallel Group Phase II Study to Assess the Safety, Tolerability and Pharmacokinetics of ADC3680B in Subjects With Partly Controlled Atopic Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 主要终点
- Evaluation of the change in frequency and severity of adverse events as a measure of safety and tolerability
研究概览
简要总结
This study is to examine the safety, tolerability, pharmacokinetics and functional activity of ADC3680B administered once daily for 28 days in subjects with partly controlled atopic asthma.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Partially controlled mild-moderate atopic asthma
- •Receiving inhaled corticosteroids
- •Non-smoker or former smoker
- •Males and females aged 18 to 55 years inclusive
- •If female, must be of non-childbearing potential
排除标准
- •History of acute severe asthma attacks
- •History of COPD
- •Other serious respiratory or other medical condition which may interfere with the outcome of the study
研究组 & 干预措施
ADC3680B oral
干预措施: ADC3680B oral (Drug)
Placebo oral
干预措施: Placebo oral (Drug)
结局指标
主要结局
Evaluation of the change in frequency and severity of adverse events as a measure of safety and tolerability
时间窗: Baseline to Day 35
Evaluation of the change in incidence of routine haematology and biochemistry abnormalities as a measure of safety
时间窗: Baseline to Day 35
Evaluation of the change in vital signs as a measure of safety
时间窗: Baseline to Day 35
Evaluation of the change in Pulmonary function as a measure of safety and tolerability
时间窗: Baseline to Day 35
Assessment of the change in asthma symptoms using the Asthma Control Questionnaire as a measure of safety and tolerability
时间窗: Baseline to Day 28
次要结局
- Exploratory assessment of exhaled nitric oxide and selected markers of inflammation in blood(Day 1 and Day 28)
- Determination of concentrations of ADC3680B in plasma(Days 1-2 and Days 28-30)