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.
- Conditions
- Chronic Hepatitis B Virus Infection
- Interventions
- Registration Number
- NCT04971512
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 26
- 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.
- 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.
- 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:
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description EDP-721 HV SAD Placebo Cohort Placebo (Part 1) Matching placebo, in one single administration EDP-721 HV MAD Placebo Cohort Placebo (Part 1) Matching placebo, once daily for 14 days EDP-721+ EDP-514 HBV MAD Cohorts EDP-721 (Part 2) 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 (Part 2) Matching placebo once daily for 42 days EDP-721+ EDP-514 HBV MAD Cohorts EDP-514 EDP-721 once daily for 14 days followed by EDP-721+EDP-514 once daily for 28 days EDP-721 HV SAD Cohorts EDP-721 EDP-721 Dose 1, Dose 2, Dose 3 and Dose 4, in one single administration EDP-721 HV MAD Cohorts EDP-721 EDP-721 Dose 1, Dose 2 and Dose 3, once daily for 14 days
- Primary Outcome Measures
Name Time Method Safety measured by adverse events Up to 98 Days in Viremic CHB MAD Cohorts
- Secondary Outcome Measures
Name Time Method 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 Cmax of EDP-514 in combination with EDP-721 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 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
Trial Locations
- Locations (1)
New Zealand Clinical Research Ltd
🇳🇿Auckland, New Zealand