[Translation] A double-blind, randomized, dose-escalating phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and food effects of single and multiple oral administration of HRS-1301 tablets in healthy subjects
Part 1:
主要目的:评价HRS-1301单次给药在健康受试者中的安全性和耐受性。
次要目的:评价HRS-1301单次给药在健康受试者中的PK特征;评价HRS-1301单次给药在健康受试者中的PD特征;评价食物对HRS-1301 PK和PD特征的影响。
探索性目的:评价HRS-1301对健康受试者QT间期的影响;评价HRS-1301在健康受试者中的代谢特征。
Part 2:
主要目的:评价HRS-1301多次给药在伴LDL-C升高的健康受试者中的安全性和耐受性。
次要目的:评价HRS-1301多次给药在伴LDL-C升高的健康受试者中的PK特征;评价HRS-1301多次给药在伴LDL-C升高的健康受试者中的PD特征。
探索性目的:评价HRS-1301暴露量与效应之间的关系;评价HRS-1301在伴LDL-C升高的健康受试者中的代谢特征。
[Translation] Part 1:
Primary objective: To evaluate the safety and tolerability of a single dose of HRS-1301 in healthy subjects.
Secondary objective: To evaluate the PK characteristics of a single dose of HRS-1301 in healthy subjects; To evaluate the PD characteristics of a single dose of HRS-1301 in healthy subjects; To evaluate the effects of food on the PK and PD characteristics of HRS-1301.
Exploratory objective: To evaluate the effects of HRS-1301 on the QT interval in healthy subjects; To evaluate the metabolic characteristics of HRS-1301 in healthy subjects.
Part 2:
Primary objective: To evaluate the safety and tolerability of multiple doses of HRS-1301 in healthy subjects with elevated LDL-C.
Secondary objective: To evaluate the PK characteristics of multiple doses of HRS-1301 in healthy subjects with elevated LDL-C; To evaluate the PD characteristics of multiple doses of HRS-1301 in healthy subjects with elevated LDL-C.
Exploratory objectives: To evaluate the relationship between HRS-1301 exposure and effect; to evaluate the metabolic characteristics of HRS-1301 in healthy subjects with elevated LDL-C.