[Translation] A randomized, double-blind, placebo-controlled, single-dose or multiple-dose escalation and food-effect Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of THDBH101 capsules (formerly known as WXSHC071 capsules) in healthy Chinese adult subjects
主要目的:评估在空腹条件下单次、多次口服不同剂量THDBH101胶囊及食物影响试验在中国健康成年受试者中的安全性、耐受性,并为后期试验推荐剂量提供依据。
次要目的: 1、评估中国健康成年受试者在空腹条件下单次和多次口服不同剂量THDBH101胶囊后的药代动力学(Pharmacokinetics, PK)特征。
2、评估食物对中国健康成年受试者单次给药THDBH101胶囊后的PK影响。
探索性目的:
1、初步评估在空腹条件下单次和多次口服给药THDBH101胶囊后的药效动力学(Pharmacodynamics, PD)特征。
2、初步评估THDBH101胶囊在血、尿液和粪便中的代谢和排泄途径。
[Translation] Primary objective: To evaluate the safety and tolerability of single and multiple oral administration of different doses of THDBH101 capsules and food effect tests in healthy Chinese adult subjects under fasting conditions, and to provide a basis for the recommended dose in later trials.
Secondary objectives: 1. To evaluate the pharmacokinetic (PK) characteristics of THDBH101 capsules in healthy Chinese adult subjects after single and multiple oral administration of different doses under fasting conditions.
2. To evaluate the effect of food on the PK of THDBH101 capsules in healthy Chinese adult subjects after a single administration.
Exploratory objectives:
1. To preliminarily evaluate the pharmacodynamic (PD) characteristics of THDBH101 capsules after single and multiple oral administration under fasting conditions.
2. To preliminarily evaluate the metabolism and excretion pathways of THDBH101 capsules in blood, urine and feces.