This is a randomized, double-blind, placebo-controlled study in viremic chronic hepatitis B subjects, assessing the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days treatment with EDP-514.
The study assesses multiple ascending doses of EDP-514 compared to placebo for 28 days in viremic chronic CHB-infected subjects not currently on treatment. Each cohort will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
25
Queen Mary Hospital
Hong Kong, Hong Kong
Chia-Yi Christian Hospital
Chiayi City, Chiayi, Taiwan
Changhua Christian Hospital
Changhua, Taiwan
Safety measured by adverse events
Time frame: Up to 84 Days in HBV MAD Cohorts
Cmax of EDP-514
Time frame: Up to 28 Days in HBV MAD Cohorts
AUC of EDP-514
Time frame: Up to 28 Days in HBV MAD Cohorts
Change from baseline in HBV DNA Viral Load Assay
Time frame: through Day 28 in HBV MAD Cohorts
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