[Translation] A randomized, double-blind, placebo-controlled phase I clinical trial evaluating TQH3821 in healthy adult subjects
主要目的:
评价TQH3821在健康受试者中多剂量、单次、多次给药的安全性和耐受性以及与甲氨蝶呤片联用的安全性和耐受性;
次要目的:
评价TQH3821在健康受试者中多剂量、单次、多次给药的药代动力学;
评价TQH3821药物代谢转化研究;
评价食物对TQH3821药代动力学的影响;
评价TQH3821与甲氨蝶呤片的药物-药物相互作用及联用后的药代动力学特性;
初步评价药效学;
初步探索代谢产物的鉴定;
[Translation] Main purpose:
Evaluate the safety and tolerability of TQH3821 in healthy subjects after multiple, single and multiple administrations, and the safety and tolerability of TQH3821 in combination with methotrexate tablets;
Secondary purpose:
Evaluate the pharmacokinetics of TQH3821 in healthy subjects after multiple, single and multiple administrations;
Evaluate the drug metabolism and transformation study of TQH3821;
Evaluate the effect of food on the pharmacokinetics of TQH3821;
Evaluate the drug-drug interaction between TQH3821 and methotrexate tablets and the pharmacokinetic properties after combined use;
Preliminary evaluation of pharmacodynamics;
Preliminary exploration of the identification of metabolites;