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NCT Number: NCT06745973

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

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.

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Key information

Conditions

Chronic Hepatitis B Blood-Borne Infections Chronic Disease Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

EPI-003

Drug

Intravenous (IV) infusion.

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs

    Time frame: From Baseline through to Day 28 postdose

Secondary outcomes

  1. Evaluation of maximum observed concentration (Cmax)

    Time frame: From Baseline through to Day 28 postdose

  2. Evaluation of maximum observed concentration (tmax)

    Time frame: From Baseline through to Day 28 postdose

  3. Evaluation of terminal elimination half-life (t1/2)

    Time frame: From Baseline through to Day 28 postdose

  4. HBsAg

    Time frame: From Baseline through to Day 365 postdose

Other outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

    Time frame: From Baseline through to Day 365 postdose

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Epigenic Therapeutics, Inc

Industry

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 24, 2024
Registry last updated
Dec 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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