Chronic Hepatitis B
Conditions
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.
Interventions
DRUGEPI-003
Intravenous (IV) infusion.
Sponsors
Epigenic Therapeutics, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs | From Baseline through to Day 28 postdose |
Secondary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). | From Baseline through to Day 365 postdose |
Countries
China
Contacts
Primary ContactFeng Epigenic Therapeutics Clinical Trials
Outcome results
None listed