[Translation] Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single/multiple administration of HBW-004285 tablets in healthy subjects
主要目的:
(1)评价HBW-004285片在健康受试者中单次给药和多次给药的安全性和耐受性;
(2)评价HBW-004285片在健康受试者中的相对生物利用度;
次要目的:
(1)评价HBW-004285片在健康受试者中单次给药和多次给药后的药代动力学(PK)特征;
(2)评价食物对HBW-004285片单次给药后药代动力学的影响;
(3)评价HBW-004285片对QTc间期的影响;
(4)评价HBW-004285片的药效动力学特征。
[Translation] Primary objectives:
(1) To evaluate the safety and tolerability of HBW-004285 tablets after single and multiple administration in healthy subjects;
(2) To evaluate the relative bioavailability of HBW-004285 tablets in healthy subjects;
Secondary objectives:
(1) To evaluate the pharmacokinetic (PK) characteristics of HBW-004285 tablets after single and multiple administration in healthy subjects;
(2) To evaluate the effect of food on the pharmacokinetics of HBW-004285 tablets after single administration;
(3) To evaluate the effect of HBW-004285 tablets on the QTc interval;
(4) To evaluate the pharmacodynamic characteristics of HBW-004285 tablets.