[Translation] A randomized, double-blind, placebo-controlled phase I clinical study evaluating the safety, tolerability, and pharmacokinetics of ALK2403 tablets in healthy trial participants.
主要目的:1.评价在健康试验参与者中单次、多次口服ALK2403片后的安全性、耐受性;2.评价食物(高脂高热量餐)对ALK2403片药代动力学的影响。次要目的:1.评价在健康试验参与者中单次、多次口服ALK2403片后的药代动力学特征;2.评价ALK2403片在健康试验参与者中的代谢与排泄特征;3.评价ALK2403片单次给药后对健康试验参与者QTc间期的影响;4.评价健康试验参与者在餐后状态下(高脂高热量餐)口服ALK2403片的安全性和耐受性。
[Translation] Primary objectives: 1. To evaluate the safety and tolerability of single and multiple oral doses of ALK2403 tablets in healthy participants; 2. To evaluate the effect of food (high-fat, high-calorie meals) on the pharmacokinetics of ALK2403 tablets. Secondary objectives: 1. To evaluate the pharmacokinetic characteristics of single and multiple oral doses of ALK2403 tablets in healthy participants; 2. To evaluate the metabolic and excretion characteristics of ALK2403 tablets in healthy participants; 3. To evaluate the effect of a single dose of ALK2403 tablets on the QTc interval in healthy participants; 4. To evaluate the safety and tolerability of oral administration of ALK2403 tablets after a meal (high-fat, high-calorie meal) in healthy participants.