A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION.
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: EDP-721 HV SAD Cohorts EDP-721 Dose 1, Dose 2, Dose 3 and Dose 4, in one single administration |
Drug: EDP-721
Oral administration (Part 1)
|
Experimental: EDP-721 HV MAD Cohorts EDP-721 Dose 1, Dose 2 and Dose 3, once daily for 14 days |
Drug: EDP-721
Oral administration (Part 1)
|
Placebo Comparator: EDP-721 HV SAD Placebo Cohort Matching placebo, in one single administration |
Drug: Placebo (Part 1)
Placebo to match EDP-721, oral administration (Part 1)
|
Placebo Comparator: EDP-721 HV MAD Placebo Cohort Matching placebo, once daily for 14 days |
Drug: Placebo (Part 1)
Placebo to match EDP-721, oral administration (Part 1)
|
Experimental: EDP-721+ EDP-514 HBV MAD Cohorts EDP-721 once daily for 14 days followed by EDP-721+EDP-514 once daily for 28 days |
Drug: EDP-721 (Part 2)
Oral administration (Part 2)
Drug: EDP-514
Oral administration
|
Placebo Comparator: EDP-721+ EDP-514 HBV MAD Placebo Cohorts Matching placebo once daily for 42 days |
Drug: Placebo (Part 2)
Placebo to match EDP-721 (Part 2)
Drug: Placebo (Part 2)
Placebo to match EDP-514
|
Outcome Measures
Primary Outcome Measures
- 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]
Secondary Outcome Measures
- 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 [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]
Eligibility Criteria
Criteria
Part 1 (HV Population):
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 65 years, inclusive.
Exclusion Criteria:
-
Clinically relevant evidence or history of illness or disease.
-
Pregnant or nursing females.
-
History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
-
A positive urine drug screen at screening or Day -1.
-
Current tobacco smokers or use of tobacco within 3 months prior to screening.
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Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
-
History of regular alcohol consumption.
-
Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose.
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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A Screening HBV DNA level in serum/plasma that is <LLOQ and
-
No HBV DNA serum/plasma test values ≥LLOQ over the previous 12 months (using an approved test)
-
CHB subjects must have been on their prescribed HBV NUC treatment with no change in regimen for 12 months prior to Screening
Inclusion Criteria (Viremic 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:
-
For subjects who are HBeAg positive at Screening, a Screening HBV DNA level in serum/plasma that is ≥20,000 IU/ml, or
-
For subjects who are HBeAg negative at Screening, a Screening HBV DNA level in serum/plasma that is ≥2,000 IU/mL, and
-
For all subjects, no HBV DNA serum/plasma test values <1,000 IU/ml over the previous 12 months (using an approved test)
-
CHB subjects must not have been on prescribed anti-HBV treatment, specifically pegIFN and/or NUC therapy for at least 12 months prior to Screening
Exclusion Criteria (Nuc-Suppressed and Viremic CHB Population):
-
A documented prior diagnosis of cirrhosis
-
Pregnant or nursing females
-
Coinfection with human immunodeficiency virus (HIV), HCV, HDV, HAV, or HEV
-
Chronic liver disease of a non-HBV etiology; coexisting liver or biliary diseases
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | New Zealand Clinical Research Ltd | Auckland | New Zealand | 1010 |
Sponsors and Collaborators
- Enanta Pharmaceuticals
Investigators
- Study Director: Enanta Pharmaceuticals, Inc, Enanta Pharmaceuticals, Inc
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EDP 721-001