[Translation] A randomized, double-blind, dose-escalating, placebo-controlled phase I clinical trial to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of HRS-7085 tablets in healthy subjects after single and multiple oral administration and to evaluate the effect of food
主要研究目的
1.评价HRS-7085片在健康受试者中单次给药(包括食物影响试验)和多次给药的安全性与耐受性
次要研究目的 1.评价HRS-7085片在健康受试者中单次给药(包括食物影响试验)和多次给药后原形HRS-7085(及其主要代谢物)的药代动力学(PK)和药效学(PD)特征。
2.评价食物对HRS-7085片在健康受试者中的PK影响;
探索性研究目的 1.评价HRS-7085片在健康受试者中的代谢特征;
2.评价HRS-7085片对健康受试者QT/QTc间期的影响。
[Translation] Main study objectives
1. To evaluate the safety and tolerability of single-dose (including food effect test) and multiple-dose HRS-7085 tablets in healthy subjects
Secondary study objectives 1. To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of HRS-7085 tablets (and its main metabolites) after single-dose (including food effect test) and multiple-dose HRS-7085 tablets in healthy subjects.
2. To evaluate the effect of food on the PK of HRS-7085 tablets in healthy subjects;
Exploratory study objectives 1. To evaluate the metabolic characteristics of HRS-7085 tablets in healthy subjects;
2. To evaluate the effect of HRS-7085 tablets on the QT/QTc interval in healthy subjects.