PHASE IIA TO EVALUATE LUNG BIOEFFICACY OF DMP777 IN ADULTS W/ Cystic Fibrosis

这项研究是一个开放标签、多剂量、剂量递增的方案，以评估口服药物DMP777的安全性和初步疗效，该药物可减少由白细胞（称为中性粒细胞）过度活跃引起的肺部炎症。过度的炎症活动是由一种叫做弹性蛋白酶的化学物质引起的；DMP777阻断这种活性，因此是一种抗炎药。在该方案中，通过使用支气管肺泡灌洗技术获取肺液样本来评估囊性纤维化患者肺液中药物的存在，还评估这些液在基线和接受药物后的炎症细胞和化学物质水平。人体对DMP777代谢的处理是通过多次服用后肺部和血液水平的测量来评估的。

This study is an open-label, multiple dose, dose-escalation protocol to evaluate the safety and preliminary efficacy of an orally administered drug, DMP777, which reduces the inflammation in the lungs caused by excessive activity of white blood cells called neutrophils. The excessive inflammatory activity is due to a chemical called elastase; DMP777 blocks this activity, and is thus an anti-inflammatory drug. In this protocol, patients with cystic fibrosis are evaluated for the presence of the drug in lung fluids by obtaining samples of lung fluids using a technique called bronchoalveolar lavage, these fluids are also assessed for levels of inflammatory cells and chemicals at baseline and after receiving the drug. The body's handling of metabolism of DMP777 is assessed by measures of lung and blood levels after multiple doses.