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Phase 1 Trial of the Safety, Pharmacokinetics, and Antiviral Activity of EDP-514 in Untreated Viremic Chronic Hepatitis B Patients.
Clinical and Molecular Hepatology ( IF 8.9 ) Pub Date : 2024-03-26 , DOI: 10.3350/cmh.2023.0535
Man-Fung Yuen , Wan-Long Chuang , Cheng-Yuan Peng , Wen-Juei Jeng , Wei-Wen Su , Ting-Tsung Chang , Chi-Yi Chen , Yao-Chun Hsu , Guy De La Rosa , Alaa Ahmad , Ed Luo , Annie L. Conery

Oral EDP-514 is a potent core protein inhibitor of hepatitis B virus (HBV) replication, which produced a >4-log viral load reduction in HBV-infected chimeric mice with human liver cells. This study evaluated the safety, pharmacokinetics (PK), and antiviral activity of three doses of EDP-514 in treatment naïve viremic patients with HBeAg-positive or -negative chronic HBV infection.

中文翻译:

EDP​​-514 在未经治疗的病毒血症慢性乙型肝炎患者中的安全性、药代动力学和抗病毒活性的 1 期试验。

口服 EDP-514 是一种有效的乙型肝炎病毒 (HBV) 复制核心蛋白抑制剂,可使感染 HBV 的人类肝细胞嵌合小鼠的病毒载量减少 4 个对数级以上。本研究评估了三种剂量的 EDP-514 在治疗 HBeAg 阳性或阴性慢性 HBV 感染的初治病毒血症患者中的安全性、药代动力学 (PK) 和抗病毒活性。
更新日期:2024-03-26
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