Chronic Hepatitis B Virus Infection
Conditions
Keywords
First-in-Human, Single Ascending Dose, Multiple Ascending Dose, Hepatitis B virus, HBV
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.
Interventions
DRUGEDP-721
Oral administration (Part 1)
DRUGPlacebo (Part 1)
Placebo to match EDP-721, oral administration (Part 1)
DRUGEDP-721 (Part 2)
Oral administration (Part 2)
DRUGPlacebo (Part 2)
Placebo to match EDP-721 (Part 2)
DRUGEDP-514
Oral administration
Sponsors
Enanta Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion 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. * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety measured by adverse events | Up to 8 Days in HV SAD Cohorts |
Secondary
| Measure | Time frame |
|---|---|
| AUC of EDP-721 | Up to 6 Days in HV SAD 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-721 | Up to 6 Days in HV SAD 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 |
| Cmax of EDP-514 in combination with EDP-721 | Up to 28 Days in All CHB MAD Cohorts |
Countries
New Zealand
Outcome results
None listed