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

Epigenic Therapeutics, Inc

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Chronic Hepatitis B

Treatments: Drug: EPI-003

Study type: Interventional

Funder types: Industry

Identifiers

NCT06745973

EPI-003-I01

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Be between 18 and 65 years of age, inclusive, at the time of signing the informed consent form;
2. Confirmed diagnosis of CHB;
3. 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

Exclusion criteria

1. Confirmed diagnosis of liver cancer or cirrhosis;
2. Combination of other major diseases; 3 Pregnant or lactating females.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

EPI-003

Experimental group

Treatment:

Drug: EPI-003