健康受试者单次和多次口服HRS-7085片及评估食物影响的安全性、耐受性及药代动力学、药效学研究-随机、双盲、剂量递增、安慰剂对照I期临床试验
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。
A Randomized, Double-Blind, Dose-Escalation, Placebo-Controlled Phase I Clinical Trial Assessing the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS-7085 Tablets Following Single and Multiple Oral Administrations, With Evaluation of Food Effects in Healthy Subjects
This is a multicenter, randomized, double-blind, placebo-parallel-controlled, Phase I clinical trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of HRS-7085 tablets in healthy subjects, with assessment of food effects
Use the Protocol Title. A Phase 1, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and the Food Effect on the Pharmacokinetics of HRS-7085 in Healthy Participants
The study is being conducted to evaluate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of HRS-7085.
100 项与 HRS-7085 相关的专利(医药)