[Translation] A randomized, double-blind, placebo-controlled, Phase Ib study evaluating the safety, tolerability, and pharmacokinetics of SIPI6398 after multiple ascending doses in healthy subjects
主要目的 :
1. 评价 SIPI6398 片在健康受试者中多剂量递增给药(MAD)的安全性和耐受性;
次要目的 : 1. 评价 SIPI6398 片在健康受试者中多剂量递增给药的药代动力学特征和催乳素水平; 2. 通过 Fridericia 校正 (QTcF) 的 QT 间期评估 SIPI6398 对心脏安全性的影响。
[Translation] Primary objectives:
1. To evaluate the safety and tolerability of SIPI6398 tablets in healthy subjects after multiple ascending doses (MAD);
Secondary objectives: 1. To evaluate the pharmacokinetic characteristics and prolactin levels of SIPI6398 tablets in healthy subjects after multiple ascending doses; 2. To evaluate the effect of SIPI6398 on cardiac safety by QT interval corrected by Fridericia (QTcF).