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Due to adverse safety signals in Part 1 (HV)
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Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EDP-721 in healthy subjects.
Part 2 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and antiviral activity of EDP-721 in combination with EDP-514 in patients with chronic hepatitis B virus infection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDP-721 HV SAD Cohorts | Experimental | EDP-721 Dose 1, Dose 2, Dose 3 and Dose 4, in one single administration |
|
| EDP-721 HV MAD Cohorts | Experimental | EDP-721 Dose 1, Dose 2 and Dose 3, once daily for 14 days |
|
| EDP-721 HV SAD Placebo Cohort | Placebo Comparator | Matching placebo, in one single administration |
|
| EDP-721 HV MAD Placebo Cohort | Placebo Comparator | Matching placebo, once daily for 14 days |
|
| EDP-721+ EDP-514 HBV MAD Cohorts | Experimental | EDP-721 once daily for 14 days followed by EDP-721+EDP-514 once daily for 28 days |
|
| EDP-721+ EDP-514 HBV MAD Placebo Cohorts | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP-721 | Drug | Oral administration (Part 1) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by adverse events | Up to 8 Days in HV SAD Cohorts | |
| Safety measured by adverse events | Up to 21 Days in HV MAD Cohorts | |
| Safety measured by adverse events | Up to 70 Days in NUC-suppressed CHB MAD Cohorts | |
| Safety measured by adverse events | Up to 98 Days in Viremic CHB MAD Cohorts |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of EDP-721 | Up to 6 Days in HV SAD Cohorts | |
| AUC of EDP-721 | Up to 6 Days in HV SAD Cohorts | |
| Cmax of EDP-721 |
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Part 1 (HV Population):
Inclusion Criteria:
Exclusion Criteria:
Part 2 (CHB Population)
Inclusion Criteria (Nuc-Suppressed CHB Population)
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
HBsAg detectable in serum/plasma at Screening and in the most recent HBsAg serum/plasma testing at least 6 months previously.
HBV DNA levels:
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| Name | Affiliation | Role |
|---|---|---|
| Enanta Pharmaceuticals, Inc | Enanta Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Zealand Clinical Research Ltd | Auckland | 1010 | New Zealand |
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Matching placebo once daily for 42 days
|
| Placebo (Part 1) |
| Drug |
Placebo to match EDP-721, oral administration (Part 1) |
|
| EDP-721 (Part 2) | Drug | Oral administration (Part 2) |
|
| Placebo (Part 2) | Drug | Placebo to match EDP-721 (Part 2) |
|
| EDP-514 | Drug | Oral administration |
|
| Placebo (Part 2) | Drug | Placebo to match EDP-514 |
|
| Up to 18 Days in HV MAD Cohorts |
| AUC of EDP-721 | Up to 18 Days in HV MAD Cohorts |
| Cmax of EDP-721 alone and in combination with EDP-514 | Up to 28 Days in All CHB MAD Cohorts |
| AUC of EDP-721 alone and in combination with EDP-514 | Up to 28 Days in All CHB MAD Cohorts |
| Cmax of EDP-514 in combination with EDP-721 | Up to 28 Days in All CHB MAD Cohorts |
| AUC of EDP-514 in combination with EDP-721 | Up to 28 Days in All CHB MAD Cohorts |
| Change from baseline in HBV DNA Viral Load Assay | Through Day 28 in All CHB MAD Cohorts |
| Change from baseline in quantitative HBsAg | Through Day 28 in All CHB MAD Cohorts |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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