[Translation] A Phase Ia clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and food effects of single and multiple ascending doses of TM471-1 capsules in healthy adult subjects
主要研究目的:
评价中国健康成年受试者接受单、多次TM471-1胶囊给药后的安全性和耐受性;
次要研究目的:
(1)评估中国健康成年受试者接受单、多次TM471-1胶囊给药后的药代动力学(PK)特征;
(2)评估中国健康成年受试者在空腹及高脂餐条件下单次给药后食物对TM471-1胶囊PK参数的影响;
探索性研究目的:
(1)探索中国健康成年受试者接受单、多次TM471-1胶囊口服给药后的药效学(PD)指标及其与PK参数的关系;
(2)探索TM471-1胶囊口服给药后血浆中的可能代谢产物。
[Translation] Main study objectives:
To evaluate the safety and tolerability of TM471-1 capsules after single and multiple administrations in healthy Chinese adult subjects;
Secondary study objectives:
(1) To evaluate the pharmacokinetic (PK) characteristics of TM471-1 capsules after single and multiple administrations in healthy Chinese adult subjects;
(2) To evaluate the effect of food on the PK parameters of TM471-1 capsules after single administration in healthy Chinese adult subjects under fasting and high-fat meal conditions;
Exploratory study objectives:
(1) To explore the pharmacodynamic (PD) indicators and their relationship with PK parameters after single and multiple oral administrations of TM471-1 capsules in healthy Chinese adult subjects;
(2) To explore the possible metabolites in plasma after oral administration of TM471-1 capsules.