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NOT YET RECRUITING
NCT06661148
PHASE1

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

Sponsor: Epigenic Therapeutics, Inc

View on ClinicalTrials.gov

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.

Official title: A Phase 1, Open-Label, 2-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EPI-003 in Select Nucleos(t)Ide Analogue-Treated, Chronic Hepatitis B Patients.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2024-12-01

Completion Date

2027-06-30

Last Updated

2024-10-28

Healthy Volunteers

No

Interventions

DRUG

EPI-003

Intravenous (IV) infusion.

Locations (4)

Epigenic Therapeutics Investigational Site

Westmead, New South Wales, Australia

Epigenic Therapeutics Investigational Site

Hong Kong, China

Epigenic Therapeutics Investigational Site

Grafton, Auckland, New Zealand

Epigenic Therapeutics Investigational Site

Christchurch, New Zealand