An Exploratory Clinical Study Evaluating EPI-003 Injection for the Treatment of Chronic Hepatitis B

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEpigenic Therapeutics, Inc

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

Confirmed diagnosis of liver cancer or cirrhosis;

Combination of other major diseases; 3 Pregnant or lactating females.

Trial design

Treatments tested in this trial

  • EPI-003

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators