[Translation] A Phase I clinical study of the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple doses of HPG1860 in healthy Chinese subjects
主要目的:评估中国健康成年受试者单次和多次口服HPG1860药代动力学(PK)特征及安全性,与既往已获得美国成年健康受试者I期临床数据比较,验证HPG1860暴露的种族差异不敏感性,桥接已获得的美国健康受试者PK数据和安全性数据。
次要目的:评估中国健康成年受试者单次和多次口服HPG1860的药物效应(PD)特征。
[Translation] Primary objective: To evaluate the pharmacokinetic (PK) characteristics and safety of HPG1860 after single and multiple oral administration in healthy adult Chinese subjects, and to compare with the previously obtained Phase I clinical data of healthy adult U.S. subjects to verify the insensitivity of racial differences in HPG1860 exposure, and to bridge the PK data and safety data of healthy U.S. subjects.
Secondary objective: To evaluate the pharmacodynamic (PD) characteristics of HPG1860 after single and multiple oral administration in healthy adult Chinese subjects.