An Exploratory Clinical Study Evaluating EPI-003 Injection for the Treatment of Chronic Hepatitis B

Early Phase 1

Not yet recruiting

• Conditions: Chronic Hepatitis B
• Interventions: Drug: EPI-003

• Registration Number: NCT06745973
• Lead Sponsor: Epigenic Therapeutics, Inc

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-09
• Study First Submitted QC: 2024-12-18
• Last Update Submitted: 2024-12-18
• Study Start: 2024-12-20
• Study First Posted: 2024-12-24
• Last Update Posted: 2024-12-24
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Be between 18 and 65 years of age, inclusive, at the time of signing the informed consent form;
2. Confirmed diagnosis of CHB;
3. Received a stable dose of NA therapy for ≥ 6 months prior to screening and plan to continue receiving the same dose for the duration of the study

Exclusion Criteria

1. Confirmed diagnosis of liver cancer or cirrhosis;
2. Combination of other major diseases; 3 Pregnant or lactating females.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EPI-003	EPI-003	-

Primary Outcome Measures

Name	Time	Method
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs	From Baseline through to Day 28 postdose

Secondary Outcome Measures

Name	Time	Method
Evaluation of maximum observed concentration (Cmax)	From Baseline through to Day 28 postdose
Evaluation of maximum observed concentration (tmax)	From Baseline through to Day 28 postdose
Evaluation of terminal elimination half-life (t1/2)	From Baseline through to Day 28 postdose
HBsAg	From Baseline through to Day 365 postdose

Trial Locations

Locations (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, China