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

NCT06745973 | Not Yet Recruiting Early Phase 1

• 1 other identifier: EPI-003-I01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs

  From Baseline through to Day 28 postdose

Secondary Outcomes (4)

• 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

Other Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

  From Baseline through to Day 365 postdose

Study Arms (1)

EPI-003

EXPERIMENTAL

Drug: EPI-003

Interventions

EPI-003 DRUG

Intravenous (IV) infusion.

EPI-003

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be between 18 and 65 years of age, inclusive, at the time of signing the informed consent form;
• Confirmed diagnosis of CHB;
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Epigenic Therapeutics, Inc: lead

Study Sites (1)

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Feng Epigenic Therapeutics Clinical Trials

CONTACT

86-17621694653; clinical@epigenictx.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 24, 2024
• Study Start: December 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)