[Translation] Phase I clinical study on the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of single and multiple oral doses of HRS-5346 tablets in healthy subjects
主要目的:1、评估HRS-5346单次给药在健康受试者中的安全性和耐受性;2、HRS-5346多次给药在健康受试者中的安全性和耐受性;
次要目的:1、评估HRS-5346单次给药在健康受试者中的药代动力学特征和药效动力学特征;2、评估食物对HRS-5346药代动力学特征的影响;3、评估HRS-5346多次给药在健康受试者中的药代动力学特征和药效动力学特征。
[Translation] Main objectives: 1. Evaluate the safety and tolerability of a single dose of HRS-5346 in healthy subjects; 2. Evaluate the safety and tolerability of multiple doses of HRS-5346 in healthy subjects;
Secondary objectives: 1. Evaluate the pharmacokinetic and pharmacodynamic characteristics of a single dose of HRS-5346 in healthy subjects; 2. Evaluate the effect of food on the pharmacokinetic characteristics of HRS-5346; 3. Evaluate the pharmacokinetic and pharmacodynamic characteristics of multiple doses of HRS-5346 in healthy subjects.