Study of EPI-003 in Select Nucleos(t)Ide Analogue-Treated, Chronic Hepatitis B Patients

NCT06661148 | Not Yet Recruiting Phase 1

• 1 other identifier: EPI-003-001
• Study Type: interventional
• Target: 36
• Locations: 3 countries
• Sites: 4

Brief Summary

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. This study is designed to determine the safety and pharmacokinetic (PK) and pharmacodynamic (PD) profile of EPI-003 in this patient population.

Conditions

Chronic Hepatitis B; HBV (Hepatitis B Virus)

Outcome Measures

Primary Outcomes (1)

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

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

  From Baseline through to Day 28 postdose

Secondary Outcomes (4)

• Change from baseline at different follow-up time points for HBsAg, HBsAb, HBV DNA, HBV pgRNA and HBcrAg

  From Baseline (predose on Day 1) at Day 3, Day 7, Day 14, Day 28, Day 56, Day 84, Day 112, and Day 182, and Day 365 postdose for the following parameters

• Evaluation of maximum observed concentration (Cmax)

  Day 1, Day 3, Day 14, and Day 28

• Evaluation of maximum observed concentration (tmax)

  Day 1, Day 3, Day 14, and Day 28

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

  Day 1, Day 3, Day 14, and Day 28

Other Outcomes (1)

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

  Up to day365

Study Arms (1)

EPI-003 group

EXPERIMENTAL

Part A：Single Ascending Dose； Part B：Dose Expansion

Drug: EPI-003

Interventions

EPI-003 DRUG

Intravenous (IV) infusion.

EPI-003 group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 to 65 years (inclusive) at the time of signing the informed consent.
• Body mass index (BMI) ≥ 18 kg/m2 and ≤ 35 kg/m2 at Screening, and body weight of ≤ 120 kg.
• Chronic HBV infection for ≥ 6 months prior to Screening (eg, positive for serum HBsAg, HBV DNA, HBeAg for ≥ 6 months ) or serum immunoglobulin M (IgM) anti-HBc (hepatitis B core antibody) negative at Screening; AND Baseline HBsAg positive at Screening.
• Has received treatment with a NA (entecavir, tenofovir disoproxil fumarate or tenofovir alafenamide) as a stable dose for ≥ 6 months before Screening and plans to continue at the same dose level for the duration of the study. Participants may be on other NAs but require Sponsor approval before enrolment.
• HBV DNA \< LLOQ (according to local guidelines) for ≥ 6 months and at Screening
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × upper limit of normal (ULN) at Screening.
• Able and willing to attend the necessary visits to the study site.
• Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.

You may not qualify if:

• Evidence or history of liver disease of non-HBV aetiology.
• Previous history or current diagnosis of significant liver fibrosis or cirrhosis
• Liver ultrasound or other imaging with findings suggestive of HCC at any time.
• Participants with serum alpha-fetoprotein (AFP) ≥ 200 ng/mL at Screening.
• Positive test result for HIV-1 or HIV-2 that suggests a concurrent infection at Screening.
• History of acute febrile illness, symptomatic viral, bacterial, or fungal infection within 1 week before Day 1.
• History of receiving HBV vaccine or other HBV-targeted therapeutic within the 6 months before Day 1.
• Previous treatment with an HBV-targeted treatment other than NAs within the 6 months before Day 1 or planned use during the study.
• Any of the laboratory values at Screening (Screening laboratory tests may be repeated once for values thought to be erroneous OR not clinically significant as per the PI):
• Immunodeficient or autoimmune conditions due to disease.
• Chronic treatment with immunosuppressants.
• Any history of unexplained blackouts, fainting episodes, significant arrythmias, clinically significant abnormality of ECG, marked QT abnormalities, or any known risk factors for Torsade de Points
• History of anaphylaxis, hypersensitivity, or significant drug allergies.
• Received any antiplatelet or antithrombotic therapy.
• History of thrombophilia or history of a positive genetic test for Factor V Leiden and/or prothrombin 20210.

Sponsors & Collaborators

• Epigenic Therapeutics, Inc: lead

Study Sites (4)

Epigenic Therapeutics Investigational Site

Westmead, New South Wales, Australia

Location

Epigenic Therapeutics Investigational Site

Hong Kong, China

Location

Epigenic Therapeutics Investigational Site

Grafton, Auckland, New Zealand

Location

Epigenic Therapeutics Investigational Site

Christchurch, New Zealand

Location

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Epigenic Therapeutics Clinical Trials

CONTACT

86-17621694653; xinyu.feng@epigenictx.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 28, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 28, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); AU (1); NZ (2)