[Translation] Phase I study on the safety, tolerability, pharmacokinetics and pharmacodynamics of single-dose nebulized inhalation of HRS-9821 suspension in healthy subjects and multiple-dose nebulized inhalation of HRS-9821 suspension in COPD patients, as well as the pulmonary pharmacokinetics of single-dose nebulized inhalation of HRS-9821 suspension in healthy subjects
主要目的:评估健康受试者单次和COPD患者多次雾化吸入HRS-9821混悬液剂量递增的安全性和耐受性。 次要目的: 1、与安慰剂比较,健康受试者单次和COPD患者多次雾化吸入HRS-9821混悬液的支气管扩张作用和持续时间,以及其它肺量计检查指标。 2、健康受试者单次和COPD患者多次雾化吸入HRS-9821混悬液的药代动力学(PK)。3、通过肺泡灌洗(BAL)评估健康受试者单次雾化吸入HRS-9821混悬液后肺上皮衬液药物浓度和肺泡灌洗液细胞的理论细胞内浓度。
[Translation] Primary objectives: To evaluate the safety and tolerability of single-dose and multiple-dose nebulized inhalation of HRS-9821 suspension in healthy subjects and COPD patients. Secondary objectives: 1. To compare the bronchodilator effect and duration of single-dose and multiple-dose nebulized inhalation of HRS-9821 suspension in healthy subjects and COPD patients, as well as other spirometry examination indicators compared with placebo. 2. To evaluate the pharmacokinetics (PK) of HRS-9821 suspension in healthy subjects and COPD patients after single-dose nebulized inhalation. 3. To evaluate the drug concentration in the lung epithelial lining fluid and the theoretical intracellular concentration of bronchoalveolar lavage fluid cells after a single nebulized inhalation of HRS-9821 suspension in healthy subjects by bronchoalveolar lavage (BAL).