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| Name | Class |
|---|---|
| Pharmaceutical Research Associates | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDP-514 HBV MAD Cohorts | Experimental | EDP-514 capsule Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days. |
|
| EDP-514 HBV MAD Placebo Cohort | Placebo Comparator | Matching placebo, orally, once daily for 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP-514 | Drug | Oral Capsule |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by adverse events | Up to 84 Days in HBV MAD Cohorts |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of EDP-514 | Up to 28 Days in HBV MAD Cohorts | |
| AUC of EDP-514 | Up to 28 Days in HBV MAD Cohorts | |
| Change from baseline in HBV DNA Viral Load Assay |
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Inclusion Criteria:
An informed consent document signed and dated by the subject.
Healthy male and female subjects of any ethnic origin between the ages of 18 and 70 years, inclusive
HBV DNA levels:
CHB subjects must not have been on prescribed anti-HBV treatment for at least 12 months prior to Screening
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enanta Pharmaceuticals, Inc | Enanta Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Queen Mary Hospital | Hong Kong | Hong Kong | ||||
| Chia-Yi Christian Hospital |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| Drug |
Placebo to match EDP-514 |
|
| through Day 28 in HBV MAD Cohorts |
| Chiayi City |
| Chiayi |
| 600566 |
| Taiwan |
| Changhua Christian Hospital | Changhua | 500209 | Taiwan |
| Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City | 500209 | Taiwan |
| E-Da Hospital/E-DA Cancer Hospital | Kaohsiung City | 824410 | Taiwan |
| Kaohsiung Chang Gung Memorial Hospital | Kaohsiung City | 833401 | Taiwan |
| China Medical University Hospital | Taichung | 404332 | Taiwan |
| National Cheng Kung University Hospital | Tainan | 704302 | Taiwan |
| National Taiwan University Hospital | Taipei | 100229 | Taiwan |
| Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch | Taoyuan | 333423 | Taiwan |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |