Safety, pharmacokinetics and antiviral activity of ABI-H2158, a hepatitis B virus core inhibitor: a randomized, placebo-controlled phase 1 study
No Thumbnail Available
Authors
Agarwal, Kosh
Xu, Jia
Gane, Edward J.
Nguyen, Tuan T.
Ding, Yanhua
Knox, Steven J.
Alves, Katia
Evanchik, Marc
Zomorodi, Katie
Ma, Julie
Check for full-text access
Issue Date
2023
Type
Article
Language
Keywords
Alternative Title
Abstract
Treatment for chronic hepatitis B virus infection (cHBV) is mostly indefinite, with new finite-duration therapies needed. We report safety, pharmacokinetics and antiviral activity of the investigational HBV core inhibitor ABI-H2158. This Phase 1a/b study (NCT03714152) had three parts: Part A, participants received a single ascending oral dose of ABI-H2158 (5-500 mg) or placebo; Part B, participants received multiple doses of ABI-H2158 300 mg once (QD) or twice (BID) daily or placebo, for 10 days; Part C, cHBV patients received ABI-H2158 (100, 300, or 500 mg QD or 300 mg BID) or placebo, for 14 days. Ninety-three participants enrolled. In Parts A/B, there were no serious adverse events (SAEs) or deaths, and all treatment-emergent AEs (TEAEs) were Grade 1. In Part C, two patients had Grade 3 TEAEs unrelated to ABI-H2158; there were no deaths, SAEs or Grade 4 TEAEs. In Part A, median time to maximum ABI-H2158 plasma concentration (T
Description
Citation
Publisher
License
Journal
Journal of Viral Hepatitis
Volume
30
Issue
3