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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Intravenous (IV) infusion.
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs
Time frame: From Baseline through to Day 28 postdose
Evaluation of maximum observed concentration (Cmax)
Time frame: From Baseline through to Day 28 postdose
Evaluation of maximum observed concentration (tmax)
Time frame: From Baseline through to Day 28 postdose
Evaluation of terminal elimination half-life (t1/2)
Time frame: From Baseline through to Day 28 postdose
HBsAg
Time frame: From Baseline through to Day 365 postdose
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