Hangzhou Bangshun Pharmaceutical Co Ltd

Main study objectives: 1 To quantitatively analyze the total radioactivity in excreta after oral administration of [14C]bangretinib to healthy male subjects, and obtain the cumulative excretion rate and main excretion pathway of human radioactivity; 2 To investigate the distribution of [14C]bangretinib in whole blood and plasma and the pharmacokinetics of total radioactivity in plasma after a single oral administration of [14C]bangretinib to healthy male subjects; 3 To identify the main metabolites in plasma, urine and feces after oral administration of [14C]bangretinib to healthy male subjects, and determine the main biotransformation pathways and main metabolites (close to or greater than 10% of the total radioactivity AUC); 4 To quantitatively analyze the concentration of bangretinib and its main metabolites (if applicable) in plasma using a validated LC-MS/MS method, and obtain the pharmacokinetic parameters of bangretinib and its main metabolites (if applicable) in plasma. Secondary study objectives: To observe the safety of healthy male subjects after a single dose of [14C]bangretinib.

Main study objectives To evaluate the pharmacokinetics and relative bioavailability of the test agent Bangretinib tablets (specification: 16 mg, produced by Shandong Yaoshi Pharmaceutical Co., Ltd.) and the reference agent Bangretinib tablets (specification: 16 mg; produced by Shanghai Hequan Pharmaceutical Co., Ltd.) in healthy adult subjects after a single oral administration under fasting conditions. Secondary study objectives To evaluate the safety of the test agent Bangretinib tablets and the reference agent Bangretinib tablets in healthy adult subjects after a single oral administration under fasting conditions.

Primary objective: To evaluate the preliminary efficacy, safety and tolerability of CX1440 capsules in adult patients with persistent or chronic ITP. Secondary objective: To evaluate the pharmacokinetic and pharmacodynamic characteristics of CX1440 capsules in adult patients with persistent or chronic ITP; to explore the relationship between dose/exposure and key efficacy and safety endpoints.