[Translation] A randomized, double-blind, placebo-controlled Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of LIT-00505 capsules in Chinese healthy subjects after single and multiple doses, and a clinical study on the effect of food on pharmacokinetics and drug metabolism
主要目的:评估中国健康受试者单次和多次口服不同剂量LIT-00505胶囊的安全性和耐受性。
次要目的:1. 评估中国健康受试者单次和多次口服不同剂量LIT-00505胶囊的药代动力学特征;2. 评估中国健康受试者单次和多次口服不同剂量LIT-00505胶囊的药效动力学特征;3. 初步评估单次和多次口服LIT-00505胶囊的PK/PD相关性;4. 评估食物对健康受试者单次口服LIT-00505胶囊后药代动力学特征的影响;5.中国成年健康受试者单剂量口服LIT-00505胶囊后物质平衡及代谢转化途径。
[Translation] Primary objective: To evaluate the safety and tolerability of single and multiple oral administration of different doses of LIT-00505 capsules in healthy Chinese subjects.
Secondary objectives: 1. To evaluate the pharmacokinetic characteristics of single and multiple oral administration of different doses of LIT-00505 capsules in healthy Chinese subjects; 2. To evaluate the pharmacodynamic characteristics of single and multiple oral administration of different doses of LIT-00505 capsules in healthy Chinese subjects; 3. To preliminarily evaluate the PK/PD correlation of single and multiple oral administration of LIT-00505 capsules; 4. To evaluate the effect of food on the pharmacokinetic characteristics of LIT-00505 capsules after single oral administration in healthy subjects; 5. To evaluate the material balance and metabolic transformation pathways of LIT-00505 capsules after single oral administration in healthy Chinese adult subjects.