[Translation] A phase I clinical study on the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple oral administration of RSS0343 tablets in healthy subjects and the effect of food on the pharmacokinetics of RSS0343
评价RSS0343片在健康受试者中单次、多次口服给药的安全性和耐受性;评价RSS0343片在健康受试者中单次、多次口服给药的药代动力学(PK)特征;评价食物对RSS0343 PK特征的影响;评价RSS0343片在健康受试者中多次口服给药的PD特征;探索RSS0343片在健康受试者血浆和尿中的药物代谢特征;探索RSS0343片对健康受试者Q T/QTc间期的影响。
[Translation] To evaluate the safety and tolerability of single and multiple oral administration of RSS0343 tablets in healthy subjects; to evaluate the pharmacokinetic (PK) characteristics of single and multiple oral administration of RSS0343 tablets in healthy subjects; to evaluate the effect of food on the PK characteristics of RSS0343; to evaluate the PD characteristics of multiple oral administration of RSS0343 tablets in healthy subjects; to explore the drug metabolism characteristics of RSS0343 tablets in plasma and urine of healthy subjects; to explore the effect of RSS0343 tablets on the Q T/QTc interval in healthy subjects.