This study is an open-label, 2-Part (Single Ascending Dose \[Part 1\] And Dose Expansion) study that will evaluate the safety of EPI-003 administered to patients with chronic infection with HBV (CHB). EPI-003 is a liver-targeted antiviral therapeutic for intravenous (IV) injection that is capable of precise epigenetic modifications of the HBV genome without causing mutations in the gene sequence itself.
Be between 18 and 65 years of age, inclusive, at the time of signing the informed consent form;
Confirmed diagnosis of CHB;
Received a stable dose of NA therapy for ≥ 6 months prior to screening and plan to continue receiving the same dose for the duration of the study
Confirmed diagnosis of liver cancer or cirrhosis;
Combination of other major diseases; 3 Pregnant or lactating females.
Single group
EPI-003
DrugIntravenous (IV) infusion.
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs
Evaluation of maximum observed concentration (Cmax)
Evaluation of maximum observed concentration (tmax)
Evaluation of terminal elimination half-life (t1/2)
HBsAg
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
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This trial is not recruiting at the moment. You can still explore other options:
