NCT06661148

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

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.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Epigenic Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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)

Interventions

Type	Name	Description
DRUG	EPI-003	Intravenous (IV) infusion.

Timeline

• Start date: 2024-12-01
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2024-10-28
• Last updated: 2024-10-28

Locations

4 sites across 3 countries: Australia, China, New Zealand