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

NCT06661148 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2024-10-28

No results posted yet for this study

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

Interventions

DRUG

EPI-003

Intravenous (IV) infusion.

Sponsors & Collaborators

  • Epigenic Therapeutics, Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2027-06-30
Completion
2027-06-30

Countries

  • Australia
  • China
  • New Zealand

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06661148 on ClinicalTrials.gov