A Randomized, Subject- and Investigator-blinded, Placebo-controlled, Paralleldesign, Bronchoprovocation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of Inhaled CSJ117 in Adult Subjects With Mild Atopic Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Number of adverse events and serious adverse events
研究概览
简要总结
This is a non-confirmatory, randomized, subject and investigator blinded, placebo-controlled, parallel-design, multi-center bronchoprovocation study. Approximately 55 subjects with mild stable atopic asthma who exhibit an EAR and LAR to a common inhaled allergen will receive multiple once daily doses of inhaled CSJ117 or placebo over 12 weeks. Two sequential dose cohorts are planned for this study, Cohort 1 and Cohort 2. Cohort 2 will be split into two parts, Cohort 2a and 2b
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stable mild atopic asthma, as defined by the American Thoracic Society/ European Respiratory Society statement, who exhibit an early and late asthmatic response to a common inhaled allergen during the screening allergen inhalation challenge.
- •Throughout the screening period and at baseline, only infrequent use of inhaled short-acting beta2-agonists (less than or equal to twice weekly) to treat asthma and/or prophylactic use prior to exercise. Inhaled short-acting beta2-agonist must be withheld for 8 hours before spirometry.
排除标准
- •Hospitalization or emergency room treatment for acute asthma in the 6 months prior to screening or during the screening period.
- •Any worsening or exacerbation of asthma (e.g., an event requiring a change in treatment) in the six weeks before screening or during the screening period.
- •A history of any clinically significant chronic pulmonary disease other than mild atopic asthma, including but not limited to COPD, interstitial lung disease or bronchiectasis
- •Use of immunosuppressive medications or allergen-specific immunotherapy within 6 months prior to screening.
研究组 & 干预措施
CSJ117
low dose, medium dose, or high dose administered as a once daily inhaled dose
干预措施: CSJ117 (Drug)
Placebo
placebo comparator administered as once daily inhaled dose
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Number of adverse events and serious adverse events
时间窗: 12 weeks
An AE is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Study drug includes the investigational drug under evaluation and the comparator drug or placebo that is given during any phase of the study. Adverse events starting on or after the time of the first inhalation of study drug are classified as a treatment emergent adverse event.
Late asthmatic response as measured by the AUC for time adjusted percent decrease in FEV1
时间窗: 12 weeks
Late asthmatic response (LAR) is considered a ≥ 15% fall in FEV1 between 3 and 7 hours after an allergen inhalation challenge. The AUC for time adjusted percent decrease in FEV1 will be compared between CSJ117 and placebo groups.
Late asthmatic response as measured by the maximum percentage decrease in FEV1
时间窗: 12 weeks
Late asthmatic response (LAR) is considered a ≥ 15% fall in FEV1 between 3 and 7 hours after an allergen inhalation challenge. The maximum percentage decrease in FEV1 will be compared between CSJ117 and placebo groups.
次要结局
- Late asthmatic response as measured by the minimum absolute FEV1(6 weeks and 12 weeks)
- Measurement of CSJ117 serum concentration and calculation of Tmax(12 weeks)
- Measurement of CSJ117 serum concentration and calculation of Cmax(12 weeks)
- Early asthmatic response as measured by the time adjusted AUC percent decrease in FEV1(6 weeks and 12 weeks)
- Measurement of CSJ117 serum concentration and calculation of Lambda_z(12 weeks)
- Measurement of CSJ117 serum concentration and calculation of T1/2(12 weeks)
- Early asthmatic response as measured by the maximum percentage decrease in FEV1(6 weeks and 12 weeks)
- Late asthmatic response as measured by the maximum percentage decrease in FEV1(6 weeks)
- Measurement of CSJ117 serum concentration and calculation of AUCtau(12 weeks)
- Early asthmatic response as measured by the minimum of the absolute in FEV1(6 weeks and 12 weeks)
- Late asthmatic response as measured by the time adjusted AUC in FEV1(6 weeks)
- Measurement of CSJ117 serum concentration and calculation of Ctrough)(12 weeks)
- Measurement of CSJ117 serum concentration and calculation of Racc(12 weeks)