Shanghai Changsen Pharmaceutical Co., Ltd.

Main research objectives: 1) To quantitatively analyze the total radioactivity in the excreta of male healthy subjects after a single oral administration of [14C]LW402, and obtain the total recovery rate of human radioactivity, excretion data and main excretion pathways; 2) To quantitatively analyze the total radioactivity in whole blood and plasma of male healthy subjects after a single oral administration of [14C]LW402, obtain the pharmacokinetic parameters of total radioactivity in whole blood (if applicable) and plasma, and investigate the distribution of total radioactivity in whole blood and plasma; 3) To quantitatively analyze the radioactive metabolite profiles in human plasma, urine and feces of male healthy subjects after a single oral administration of [14C]LW402, identify the main metabolites, and determine the metabolic pathways and elimination pathways of LW402 in the human body. Secondary study objectives: 1) To quantitatively analyze the concentrations of LW402 and its metabolite LW40241 and other metabolites (if applicable) in plasma using a validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method, and to obtain the pharmacokinetic parameters of LW402 and its metabolite LW40241 and other metabolites (if applicable) in plasma; 2) To observe the safety of [14C]LW402 after a single oral administration in healthy male subjects.

Primary objective: To evaluate the preliminary efficacy of LW402 tablets in patients with moderate to severe AD. Secondary objective: To evaluate the safety and tolerability characteristics of LW402 tablets in patients with moderate to severe AD. Exploratory objective: To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of LW402 tablets in patients with moderate to severe AD.