Tibet Haisco Pharmaceutical Co. Ltd.

Main research objectives 1. Quantitatively analyze the total radioactivity in the excreta of healthy subjects after oral administration of [14C]HSK39297, and obtain the human radioactivity recovery rate and main excretion pathway; 2. Quantitatively analyze the total radioactivity in whole blood and plasma of subjects after a single oral administration of [14C]HSK39297, obtain the pharmacokinetic parameters of total radioactivity in plasma and whole blood (if applicable), and investigate the distribution of total radioactivity in whole blood and plasma; 3. Investigate the radioactive metabolite spectrum of plasma, urine and feces of subjects after oral administration of [14C]HSK39297, identify the main metabolites, and determine the metabolic pathways and elimination pathways. Secondary study objectives 1. To quantitatively analyze the plasma concentration of parent drug HSK39297 and other metabolites (if applicable) by using the validated liquid chromatography tandem mass spectrometry (LC-MS/MS) method, and then evaluate the pharmacokinetic parameters of parent drug HSK39297 and other metabolites (if applicable) in plasma; 2. To observe the safety of subjects after a single dose of [14C]HSK39297.

Primary objective To evaluate the effectiveness of HSK39297 tablets in the treatment of patients with primary IgA nephropathy. Secondary objectives 1. To evaluate the effect of HSK39297 tablets on renal function indicators in patients with primary IgA nephropathy; 2. To evaluate the safety of HSK39297 tablets in the treatment of patients with primary IgA nephropathy; 3. To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of HSK39297 tablets in the treatment of patients with primary IgA nephropathy.

To evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of HSK39004 inhalation suspension after single and multiple administration in healthy subjects; To evaluate the safety, tolerability and pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of HSK39004 inhalation suspension after multiple administration in COPD patients.