A First-in-Human Trial of GLS4, a Novel Inhibitor of Hepatitis B Virus Capsid Assembly, following Single- and Multiple-Ascending-Oral-Dose Studies with or without Ritonavir in Healthy Adult Volunteers

Author:

Zhao Nan1,Jia Bo1,Zhao Hong2,Xu Junyu1,Sheng Xiaoyan1,Luo Lin3,Huang Zhangma3,Wang Xingan3,Ren Qingyun3,Zhang Yingjun3,Zhao Xia1,Cui Yimin1

Affiliation:

1. Department of Pharmacy, Peking University First Hospital, Beijing, China

2. Department of Infectious Diseases, Center for Liver Disease, Peking University First Hospital, Beijing, China

3. The State Key Laboratory of Anti-Infective Drug Development, HEC R&D Center, Sunshine Lake Pharma Co., Ltd., Dongguan, China

Abstract

GLS4 is a novel inhibitor of the hepatitis B virus (HBV) capsid assembly with inhibitory activities against nucleot(s)ide-resistant HBV strains. This study investigated the pharmacokinetics, safety, and tolerability of GLS4 and the effects of food and ritonavir in healthy adults. GLS4 was administered in a single-ascending-dose study over 1 to 240 mg and multiple-ascending-dose study that ranged from 30 mg once daily to 180 mg three times daily.

Funder

State Key Laboratory of Anti-Infective Drug Development

MOST | National Major Science and Technology Projects of China

Publisher

American Society for Microbiology

Subject

Infectious Diseases,Pharmacology (medical),Pharmacology

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