A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Dose Ranging, Phase 1b/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics and Early Efficacy of Inhaled KIT2014 Over 7 Days of Treatment in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 4
- 主要终点
- Treatment-emergent adverse events(TEAEs),serious adverse events(SAEs)
研究概览
简要总结
Study investigating the safety, tolerability, pharmacokinetics and early efficacy with KIT2014 over 7 days of treatment in moderate to severe chronic obstructive pulmonary disease patients.
详细描述
This is a Multicentre, Randomised, Double-Blind, Placebo-Controlled, Dose Ranging, Phase 1b/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics and Early Efficacy of Inhaled KIT2014 Over 7 Days of Treatment in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease. The study will be conducted in 3 ascending dose cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects
- •Adult males and females, 40 to 80 years of age (inclusive) at screening.
- •Current or former cigarette smokers with a ≥10 pack-year smoking history
- •Established physician diagnosis of COPD with associated symptoms defined by the GOLD guidelines for ≥ 12 months of screening.
- •FEV1 post-bronchodilator of 40% to 80% of predicted normal at Screening
- •Current symptoms of COPD, including bronchitis and/or dyspnoea on moderate exertion at screening.
排除标准
- •History of life-threatening COPD
- •Chronic obstructive pulmonary disease exacerbation requiring oral or parenteral corticosteroids or hospitalisation within 3 months of Screening
- •Other clinically active, physician diagnosed moderate to severe respiratory disorders that could interfere with study assessments or confound results (e.g., asthma, bronchiectasis, pulmonary fibrosis, interstitial lung diseases, bronchiolitis obliterans, lung cancer, cor pulmonale, pulmonary hypertension, uncontrolled sleep apnoea, active tuberculosis).
- •Other inclusion/exclusion eligibility criteria apply.
研究组 & 干预措施
KIT2014
24 participants with Chronic Obstructive Pulmonary Disease to be enrolled in 3 cohorts, up to 3 dose levels
干预措施: KIT2014 (Drug)
Placebo
12 participants with Chronic Obstructive Pulmonary Disease to be enrolled in 3 cohorts, up to 3 dose levels
干预措施: Placebo (Drug)
结局指标
主要结局
Treatment-emergent adverse events(TEAEs),serious adverse events(SAEs)
时间窗: From first dose to post-treatment follow up visit on Day 9.
Incidence, type, severity, and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment.
次要结局
未报告次要终点