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.

Epigenic Therapeutics, Inc1 site in 1 country36 target enrollmentDecember 1, 2024

ConditionsChronic Hepatitis B HBV (Hepatitis B Virus)

InterventionsEPI-003

DrugsEPI-003

Overview

Phase: Phase 1
Intervention: EPI-003
Conditions: Chronic Hepatitis B
Sponsor: Epigenic Therapeutics, Inc
Enrollment: 36
Locations: 1
Primary Endpoint: Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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. This study is designed to determine the safety and pharmacokinetic (PK) and pharmacodynamic (PD) profile of EPI-003 in this patient population.

Registry

clinicaltrials.gov

Start Date

December 1, 2024

End Date

June 30, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Epigenic Therapeutics, Inc

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Aged 18 to 65 years (inclusive) at the time of signing the informed consent.
•Body mass index (BMI) ≥ 18 kg/m2 and ≤ 35 kg/m2 at Screening, and body weight of ≤ 120 kg.
•Chronic HBV infection for ≥ 6 months prior to Screening (eg, positive for serum HBsAg, HBV DNA, HBeAg for ≥ 6 months ) or serum immunoglobulin M (IgM) anti-HBc (hepatitis B core antibody) negative at Screening; AND Baseline HBsAg positive at Screening.
•Has received treatment with a NA (entecavir, tenofovir disoproxil fumarate or tenofovir alafenamide) as a stable dose for ≥ 6 months before Screening and plans to continue at the same dose level for the duration of the study. Participants may be on other NAs but require Sponsor approval before enrolment.
•HBV DNA \< LLOQ (according to local guidelines) for ≥ 6 months and at Screening
•Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2 × upper limit of normal (ULN) at Screening.
•Able and willing to attend the necessary visits to the study site.
•Able and willing to provide written informed consent after the nature of the study has been explained and prior to the commencement of any study procedures.

Exclusion Criteria

•Evidence or history of liver disease of non-HBV aetiology.
•Previous history or current diagnosis of significant liver fibrosis or cirrhosis
•Liver ultrasound or other imaging with findings suggestive of HCC at any time.
•Participants with serum alpha-fetoprotein (AFP) ≥ 200 ng/mL at Screening.
•Positive test result for HIV-1 or HIV-2 that suggests a concurrent infection at Screening.
•History of acute febrile illness, symptomatic viral, bacterial, or fungal infection within 1 week before Day
•History of receiving HBV vaccine or other HBV-targeted therapeutic within the 6 months before Day
•Previous treatment with an HBV-targeted treatment other than NAs within the 6 months before Day 1 or planned use during the study.
•Any of the laboratory values at Screening (Screening laboratory tests may be repeated once for values thought to be erroneous OR not clinically significant as per the PI):
•Immunodeficient or autoimmune conditions due to disease.

Arms & Interventions

EPI-003 group

Part A：Single Ascending Dose； Part B：Dose Expansion

Intervention: EPI-003

Outcomes

Primary Outcomes

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

Time Frame: From Baseline through to Day 28 postdose

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

Secondary Outcomes

Change from baseline at different follow-up time points for HBsAg, HBsAb, HBV DNA, HBV pgRNA and HBcrAg(From Baseline (predose on Day 1) at Day 3, Day 7, Day 14, Day 28, Day 56, Day 84, Day 112, and Day 182, and Day 365 postdose for the following parameters)
Evaluation of maximum observed concentration (Cmax)(Day 1, Day 3, Day 14, and Day 28)
Evaluation of maximum observed concentration (tmax)(Day 1, Day 3, Day 14, and Day 28)
Evaluation of terminal elimination half-life (t1/2)(Day 1, Day 3, Day 14, and Day 28)