A Two Part, Randomised, Double-blind, Placebo-controlled, Phase 2 Parallel Group Study to Evaluate the Safety and Efficacy of Intravenously-Administered SelK2 on Airway Responses Following Allergen Challenge in Subjects With Asthma (Part 1) and to Evaluate the Safety and Efficacy of Intravenously-Administered SelK2 in Subjects With Chronic Obstructive Pulmonary Disease (Part 2)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- Change from baseline in percentage of neutrophils in sputum (Part 2).
研究概览
简要总结
This study has two parts. The main purpose of Part 1 of this study will be to examine how safe and effective two doses of SelK2 is on participants with mild asthma. Lung function and inflammatory cell numbers will be measured in response to the administration of an allergen (a compound to which the participant is allergic) into the lungs in the presence or absence of SelK2. Part 2 of this study will examine how safe and effective one dose of SelK2 is on participants with chronic obstructive pulmonary disease (COPD). Lung function and inflammatory cell numbers will be measured in COPD patients in the presence or absence of SelK2. SelK2 may block the movement of key inflammatory cells into the lungs and consequently improve lung function in these two patient populations.
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
- Quadruple (Participant, Care Provider, 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
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SelK2 (Part 1)
I.V., multiple-dose (Day 1 and Day 22)
干预措施: SelK2 (Part 1) (Drug)
Placebo (Part 1)
I.V., multiple-dose (Day 1 and Day 22)
干预措施: Placebo (Part 1) (Drug)
SelK2 (Part 2)
I.V., single-dose (Day 1)
干预措施: SelK2 (Part 2) (Drug)
Placebo (Part 2)
I.V., single-dose (Day 1)
干预措施: Placebo (Part 2) (Drug)
结局指标
主要结局
Change from baseline in percentage of neutrophils in sputum (Part 2).
时间窗: Change from baseline to Day 22
Maximum percentage fall in FEV1 from pre-challenge between 3 and 8 hours (LAR) after administration of allergen inhalation challenge (Part 1).
时间窗: Pre-challenge to between 3 and 8 hours after administration of allergen inhalation challenge
次要结局
- Change from baseline and change during challenge in percentage of eosinophils in sputum (Part 1)(Change from baseline to 8 and 24 hours post allergen challenge)
- Maximum percentage fall in FEV1 and AUC for the percent fall in FEV1 from pre-challenge between 0 and 2 hours after the administration of allergen inhalation challenge (EAR) (Part 1).(Pre-challenge to between 0 and 2 hours after the administration of allergen inhalation challenge)
- Maximum percentage fall in FEV1 and AUC for the percent fall in FEV1 between 0 and 8 hours (entire asthmatic response) after the administration of allergen inhalation challenge (Part 1)(Pre-challenge to between 0 and 8 hours after the administration of allergen inhalation challenge)
- Change from baseline in percentage of neutrophils (Part 2).(Change from baseline to Days 4, 8, 15, and 29)
- Change from baseline in pre-challenge FEV1 (Part 1).(Change from baseline to Day 29)
- AUC for the percent fall in FEV1 from pre-challenge between 3 and 8 hours (LAR) after the administration of allergen inhalation challenge (Part 1).(Pre-challenge to between 3 and 8 hours after administration of allergen inhalation challenge)
- Change from baseline in absolute and percentage cell counts for immune cells in induced sputum samples and blood (Part 2).(Change from baseline to Days 4, 8, 15, 22, and 29)
- Change from baseline in pre- and post-bronchodilator impulse oscillometry (IOS) (Part 2).(Change from baseline to Days 4, 8, 15, 22, and 29)
- Change from baseline in Breathlessness Cough and Sputum Scale (BCSS) scores (Part 2).(Change from baseline to Days 4, 8, 15, 22, and 29)
- Change from baseline in FEV1 and post-bronchodilator FEV1 (Part 2).(Change from baseline to Days 4, 8, 15, 22, and 29)
- Change from baseline in pre- and post-bronchodilator whole body plethysmography (Part 2).(Change from baseline to Days 4, 8, 15, 22, and 29)
- Change from baseline in COPD Assessment Test (CAT) scores (Part 2).(Change from baseline to Days 4, 8, 15, 22, and 29)