[Translation] A randomized, double-blind, dose-finding, multicenter phase II clinical trial of the efficacy and safety of HK241 nebulized inhalation solution in the treatment of bronchiectasis in adults with pulmonary Pseudomonas aeruginosa infection
主要研究目的:探索不同剂量的HK241雾化吸入溶液相对于安慰剂用于治疗伴肺部铜绿假单胞菌感染的成人支气管扩张症的有效性。
次要研究目的:评价不同剂量的HK241雾化吸入溶液相对于安慰剂用于治疗伴肺部铜绿假单胞菌感染的成人支气管扩张症的安全性。评价不同剂量的HK241雾化吸入溶液在伴肺部铜绿假单胞菌感染的成人支气管扩张症患者的药代动力学(PK)特征。
[Translation] Primary study objective: To investigate the efficacy of different doses of HK241 nebulized inhalation solution compared with placebo in the treatment of adults with bronchiectasis and concurrent Pseudomonas aeruginosa pulmonary infection.
Secondary study objectives: To evaluate the safety of different doses of HK241 nebulized inhalation solution compared with placebo in the treatment of adults with bronchiectasis and concurrent Pseudomonas aeruginosa pulmonary infection. To evaluate the pharmacokinetic (PK) profile of different doses of HK241 nebulized inhalation solution in adult patients with bronchiectasis and concurrent Pseudomonas aeruginosa pulmonary infection.