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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Intravenous (IV) infusion.
Epigenic Therapeutics Investigational Site
Westmead, New South Wales, Australia
Epigenic Therapeutics Investigational Site
Hong Kong, China
Epigenic Therapeutics Investigational Site
Grafton, Auckland, New Zealand
Epigenic Therapeutics Investigational Site
Christchurch, New Zealand
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Time frame: From Baseline through to Day 28 postdose
Change from baseline at different follow-up time points for HBsAg, HBsAb, HBV DNA, HBV pgRNA and HBcrAg
Change from baseline at different follow-up time points for HBsAg, HBsAb, HBV DNA, HBV pgRNA and HBcrAg
Time frame: 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)
Evaluation of maximum observed concentration (Cmax)
Time frame: Day 1, Day 3, Day 14, and Day 28
Evaluation of maximum observed concentration (tmax)
Evaluation of maximum observed concentration (tmax)
Time frame: Day 1, Day 3, Day 14, and Day 28
Evaluation of terminal elimination half-life (t1/2)
Evaluation of terminal elimination half-life (t1/2)
Time frame: Day 1, Day 3, Day 14, and Day 28
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