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

December 18, 2024 updated by: Epigenic Therapeutics, Inc
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Shanghai, China
        • Renji Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EPI-003
Drug: EPI-003
Intravenous (IV) infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs
Time Frame: From Baseline through to Day 28 postdose
From Baseline through to Day 28 postdose

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of maximum observed concentration (Cmax)
Time Frame: From Baseline through to Day 28 postdose
From Baseline through to Day 28 postdose
Evaluation of maximum observed concentration (tmax)
Time Frame: From Baseline through to Day 28 postdose
From Baseline through to Day 28 postdose
Evaluation of terminal elimination half-life (t1/2)
Time Frame: From Baseline through to Day 28 postdose
From Baseline through to Day 28 postdose
HBsAg
Time Frame: From Baseline through to Day 365 postdose
From Baseline through to Day 365 postdose

Other Outcome Measures

Outcome Measure
Time Frame
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Time Frame: From Baseline through to Day 365 postdose
From Baseline through to Day 365 postdose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epigenic Therapeutics, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 20, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 9, 2024

First Submitted That Met QC Criteria

December 18, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 18, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPI-003-I01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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