Clinical Research Directory
Browse clinical research sites, groups, and studies.
Study of EPI-003 in Select Nucleos(t)Ide Analogue-Treated, Chronic Hepatitis B Patients
Sponsor: Epigenic Therapeutics, Inc
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
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