Bojiyuan (Shanghai) Biopharmaceutical Co., Ltd.

The absorption, metabolism and excretion of [14C] BGT-002 in healthy adult male subjects after a single oral dose were investigated, revealing the overall pharmacokinetic characteristics and safety of BGT-002 in humans, and providing a reference for the rational clinical application of this drug.

Primary objective: To evaluate the efficacy of different doses of BGT-002 tablets added to statin therapy in lowering low-density lipoprotein cholesterol (LDL-C) in patients with primary hypercholesterolemia, as well as the relationship between dose and efficacy. Secondary objective: To evaluate the safety of BGT-002 tablets in patients with primary hypercholesterolemia; to evaluate the pharmacokinetic characteristics of BGT-002 tablets in patients with primary hypercholesterolemia.

Primary study objectives: To evaluate the pharmacokinetic effects of BGT-002 on atorvastatin in healthy subjects; To evaluate the pharmacokinetic effects of BGT-002 on rosuvastatin in healthy subjects; To evaluate the pharmacokinetic effects of BGT-002 on simvastatin in healthy subjects; Secondary study objectives: To evaluate the safety and tolerability of subjects after oral administration of BGT-002 in combination with atorvastatin; To evaluate the safety and tolerability of subjects after oral administration of BGT-002 in combination with rosuvastatin; To evaluate the safety and tolerability of subjects after oral administration of BGT-002 in combination with simvastatin. Exploratory objectives: To explore the pharmacokinetic characteristics of subjects after multiple oral administration of BGT-002; To explore the pharmacodynamic characteristics of subjects after multiple oral administration of BGT-002.