[Translation] A phase I clinical study evaluating the safety, tolerability, pharmacokinetic characteristics of HHT109 capsules in healthy participants, including single-dose, multiple-dose escalation, and the effect of food on pharmacokinetics.
主要目的:评价健康参与者单次及多次服用HHT109胶囊后的安全性、耐受性。确定健康参与者单药口服HHT109胶囊的MTD,为后期临床试验给药方案提供安全的剂量范围。
次要目的:评价健康参与者单次及多次服用HHT109胶囊后的药代动力学特征;评价健康参与者空腹及餐后状态下服用HHT109胶囊的药代动力学特征,评价食物对药代动力学特征的影响。
探索性目的:评价健康参与者单次及多次服用HHT109胶囊后的药效动力学特征;健康参与者单次及多次服用HHT109胶囊后对QT间期的影响。
[Translation] Primary Objective: To evaluate the safety and tolerability of HHT109 capsules in healthy participants after single and multiple administrations. To determine the median dose (MTD) of HHT109 capsules in healthy participants as a single oral dose, providing a safe dosage range for later clinical trials.
Secondary Objectives: To evaluate the pharmacokinetic characteristics of HHT109 capsules in healthy participants after single and multiple administrations; to evaluate the pharmacokinetic characteristics of HHT109 capsules administered in healthy participants under fasting and postprandial conditions; and to evaluate the effect of food on pharmacokinetic characteristics.
Exploratory Objectives: To evaluate the pharmacodynamic and pharmacokinetic characteristics of HHT109 capsules in healthy participants after single and multiple administrations; and to evaluate the effect of HHT109 capsules on the QT interval in healthy participants after single and multiple administrations.