Zhejiang Xinghao Pengbo Pharmaceutical Co., Ltd.

(1) Quantitative analysis of the total radioactivity in the excreta of male healthy subjects after a single oral administration of [14C]XH-S004, to obtain data on the excretion rate of radioactivity in humans and the main excretion pathways; (2) Quantitative analysis of the radioactive metabolite profiles in human plasma, urine, and feces of male healthy subjects after a single oral administration of [14C]XH-S004, to identify the main metabolites, and to determine the metabolic pathways and elimination pathways of XH-S004 in humans; (3) Quantitative analysis of the total radioactivity in whole blood and plasma of male healthy subjects after a single oral administration of [14C]XH-S004, to obtain pharmacokinetic parameters of the total radioactivity in plasma and whole blood (if applicable), and to investigate the distribution of the total radioactivity in whole blood and plasma.

(1) Quantitative analysis of the total radioactivity in the excreta of healthy male subjects after a single oral administration of [14C]XH-S003, to obtain the human radioactivity recovery rate data and the main excretion pathway; (2) Quantitative analysis of the radioactive metabolite profiles in human plasma, urine, and feces of healthy male subjects after a single oral administration of [14C]XH-S003, to identify the main metabolites, and to determine the metabolic pathways and elimination pathways of XH-S003 in the human body; (3) Quantitative analysis of the total radioactivity in whole blood and plasma of healthy male subjects after a single oral administration of [14C]XH-S003, to obtain the pharmacokinetic parameters of the total radioactivity in plasma and whole blood (if applicable), and to investigate the distribution of the total radioactivity in whole blood and plasma.

1. Efficacy Objective: To evaluate the effect of EXPD-101 on the annualized incidence of acute exacerbations of moderate to severe chronic obstructive pulmonary disease (COPD) over a 52-week treatment period compared to placebo. 2. Safety Objective: To assess the safety and tolerability of EXPD-101 compared to placebo based on adverse events (AEs), vital signs, electrocardiogram (ECG), physical examination, and clinical laboratory evaluations.