A Single Center, Open Label, Stepwise, Dose Profiling Study to Evaluate the Efficacy and Safety of Four Dose Regimens of Inhaled TPI ASM8 in Patients With Allergic Asthma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Sputum eosinophils (%) on Day 4 versus Screening for each dose level.
研究概览
简要总结
During this proposed clinical trial, the investigators intend to evaluate the pharmacodynamic anti-inflammatory properties and safety of TPI ASM8, by investigating the effect on sputum eosinophils and the airway responses during an allergen challenge at different dose levels.
详细描述
The early and late asthmatic response were both significantly attenuated by the highest dose of ASM8. The methacholine challenge and other parameters (ECP, mRNA knockdown on CCR3 and B-Chain of IL-3-Il-5 and GMCSF were attenuated by ASM8.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women 18 to 65 years of age
- •Generally good health; steroid naïve (or who have not taken inhaled/oral corticosteroid within last month) mild to moderate, stable, allergic asthma as defined by ATS criteria
- •History of episodic wheeze and shortness of breath
- •Forced expiratory volume in one second (FEV1) at baseline ≥ 70% of the predicted value
- •Able to comprehend and follow all required study procedures; willing and able to sign an informed consent form.
排除标准
- •Significant acute or chronic medical or psychiatric illness
- •Known coagulopathy, worsening of asthma or respiratory infection in the preceding 6 weeks
- •Use of inhaled or oral corticosteroids within the last 30 days, or need for antihistamines within 72 hours of each allergen or methacholine challenge, immunosuppressives, nonsteroidal anti-inflammatory drugs, or anticoagulants (intermittent doses of short-acting β2-agonist are allowed).
研究组 & 干预措施
Dose level No.1
TPI ASM8 1 mg BID
干预措施: TPI ASM8 (Drug)
Dose level No.2
TPI ASM8 2 mg BID
干预措施: TPI ASM8 (Drug)
Dose level No.3
TPI ASM8 4mg BID
干预措施: TPI ASM8 (Drug)
Dose level No.4
TPI ASM8 8 mg Die
干预措施: TPI ASM8 (Drug)
结局指标
主要结局
Sputum eosinophils (%) on Day 4 versus Screening for each dose level.
时间窗: 7 and 24 hrs post-allergen challenge
次要结局
- Plasma and sputum pharmacokinetic profile at the two highest dose levels.(Dose level 3 and 4)
- Safety and tolerability.(Throughout the study)