[Translation] A Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic characteristics and food effects of single and multiple doses of THDBH110 capsules in healthy Chinese adult subjects
主要目的:评估健康成人单次服用THDBH110胶囊后的安全性和耐受性;评估健康成人多次服用THDBH110胶囊后的安全性和耐受性;
次要目的:评估健康成人单次服用THDBH110胶囊后的药代动力学特征;评估健康成人多次服用THDBH110胶囊后的药代/药效动力学特征;评估食物对健康成人服用THDBH110胶囊后的药代动力学特征的影响;评估健康成人单次服用THDBH110胶囊后对QTc间期的影响;初步探索健康成人服用THDBH110胶囊后在人体内的代谢转化情况。
[Translation] Primary purpose: To evaluate the safety and tolerability of THDBH110 capsules after a single dose in healthy adults; To evaluate the safety and tolerability of THDBH110 capsules after multiple doses in healthy adults;
Secondary purpose: To evaluate the pharmacokinetic characteristics of THDBH110 capsules after a single dose in healthy adults; To evaluate the pharmacokinetic/pharmacodynamic characteristics of THDBH110 capsules after multiple doses in healthy adults; To evaluate the effect of food on the pharmacokinetic characteristics of THDBH110 capsules after healthy adults take THDBH110 capsules; To evaluate the effect of a single dose of THDBH110 capsules on the QTc interval in healthy adults; To preliminarily explore the metabolic transformation of THDBH110 capsules in the human body after healthy adults take them.