[Translation] A Phase I clinical study evaluating the safety, tolerability, and pharmacokinetic characteristics of CYH001 enteric-coated capsules under single-dose, multiple-dose, and food-related conditions in healthy participants.
1.SAD试验
主要目的:评价 CYH001 肠溶胶囊单次给药在健康参与者中的安全性和耐受性。 次要目的:评价 CYH001 肠溶胶囊单次给药在健康参与者中的药代动力学特征。 探索性目的:1、评估 CYH001 肠溶胶囊单次给药在健康参与者中是否具有潜在的 QT/QTc间期延长风险。2、CYH001 肠溶胶囊单次给药后健康参与者体内代谢产物的鉴定(如适用)。 2.MAD试验
主要目的:评价 CYH001 肠溶胶囊多次给药在健康参与者中的安全性和耐受性。 次要目的: 评价 CYH001 肠溶胶囊多次给药在健康参与者中的药代动力学特征。
3.FE试验
主要目的:评价在健康参与者中高脂餐对 CYH001 药代动力学的影响。
次要目的: 评价空腹和高脂餐后 CYH001 肠溶胶囊单次给药在健康参与者中的安全性。
[Translation] 1. SAD Trial
Primary Objective: To evaluate the safety and tolerability of a single dose of CYH001 enteric-coated capsules in healthy participants. Secondary Objective: To evaluate the pharmacokinetic characteristics of a single dose of CYH001 enteric-coated capsules in healthy participants. Exploratory Objectives: 1. To assess whether a single dose of CYH001 enteric-coated capsules carries a potential risk of QT/QTc interval prolongation in healthy participants. 2. To identify metabolites in healthy participants after a single dose of CYH001 enteric-coated capsules (if applicable).
2. MAD Trial
Primary Objective: To evaluate the safety and tolerability of multiple doses of CYH001 enteric-coated capsules in healthy participants. Secondary Objective: To evaluate the pharmacokinetic characteristics of multiple doses of CYH001 enteric-coated capsules in healthy participants.
3. FE Trial
Primary Objective: To evaluate the effect of a high-fat meal on the pharmacokinetics of CYH001 in healthy participants.
Secondary objective: To evaluate the safety of a single dose of CYH001 enteric-coated capsules administered after fasting and a high-fat meal in healthy participants.