[Translation] A single-center, double-blind, placebo-controlled, first-in-human study to evaluate the safety, tolerability, pharmacokinetic characteristics and food effects of single and repeated doses of AK0706 tablets in a Phase Ia clinical trial
1、研究 AK0706 片在受试者中的安全性和耐受性,初步评估AK0706 对 QT 间期的影响。
2、评估健康受试者单次口服 AK0706 片和 HBsAg 阳性的 ALT 正常的受试者重复口服 AK0706 的 PK 特征。
3、评估食物对健康受试者口服 AK0706 片的 PK 特征的影响。
4、检测 AK0706 可能的代谢产物类型及主要代谢产物的 PK 特征(如适用)。
[Translation] 1. To study the safety and tolerability of AK0706 tablets in subjects and preliminarily evaluate the effect of AK0706 on the QT interval.
2. To evaluate the PK characteristics of healthy subjects who took AK0706 tablets orally once and subjects who were HBsAg positive and had normal ALT after repeated oral administration of AK0706.
3. To evaluate the effect of food on the PK characteristics of healthy subjects who took AK0706 tablets orally.
4. To detect the possible metabolite types of AK0706 and the PK characteristics of the main metabolites (if applicable).