[Translation] A randomized, double-blind, placebo-controlled, dose-escalation Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of HS-10501-2 in healthy participants
本研究为一项随机、双盲、安慰剂对照、单次给药剂量递增和多次给药剂量递增的I期临床试验,以评估HS-10501-2在中国健康成人参与者中的安全性、耐受性、药代动力学(Pharmacokinetics,PK)和药效动力学(Pharmacodynamics,PD)特征以及初步探索食物效应。本试验由两部分组成(Part A和Part B),Part A为在健康参与者中开展的单次给药剂量递增(Single Ascending Dose,SAD),并在20 mg剂量组探索性研究食物效应,Part B为在健康参与者中开展的多次给药剂量递增(Multiple Dose,MD)
[Translation] This study is a randomized, double-blind, placebo-controlled, single-dose ascending and multiple-dose ascending Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of HS-10501-2 in healthy adult participants in China, as well as to preliminarily explore the food effect. This trial consists of two parts (Part A and Part B). Part A is a single ascending dose (SAD) conducted in healthy participants, and explores the food effect in the 20 mg dose group. Part B is a multiple dose escalation (MD) conducted in healthy participants.