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

这项研究是一项开放标签、多次剂量、剂量递增的方案，旨在评估口服药物DMP777的安全性和初步疗效，该药物可减少由中性粒细胞过度活动引起的肺部炎症。过度的炎症活性是由于一种名为弹性蛋白酶的化学物质；DMP777阻止了这种活性，因此是一种抗炎药物。在这项方案中，通过使用一种名为支气管肺泡灌洗的技术获取肺液样本，评估囊性纤维化患者的肺液中是否存在药物，并在基线和接受药物后评估这些肺液中炎症细胞和化学物质的水平。人体对DMP777新陈代谢的处理是通过测量多次给药后的肺和血液水平来评估的。

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.