Chronic HBV 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. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-514 in healthy adult subjects. Part 2 is randomized, double -blind, placebo-controlled study including subjects with Hepatitis B Virus. It will assess the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days of orally administered doses of EDP-514 in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection
Detailed description
Part 1 consists of two phases planned in healthy subjects: The first phase assesses single ascending doses for EDP-514 (active drug or placebo) in healthy subjects. A fasted and fed two-part cohort will also assess food effect. The second phase assesses multiple ascending doses (active drug or placebo) for 14 days in healthy subjects. Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-514 or placebo. Part 2 assesses multiple ascending doses EDP-514 (active drug or placebo) for 28 days in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection. Each cohort in Part 2 will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo.
Interventions
DRUGEDP-514
Oral Capsule; Subjects will receive either a single dose of EDP-514 on Day 1 only (SAD HV), once daily dosing of EDP-514 starting on Day 1 through Day 14 (MAD HV) or once daily dosing of EDP-514 starting on Day 1 through Day 28 (MAD HBV).
DRUGPlacebo
Placebo to match EDP-514
Sponsors
Pharmaceutical Research Associates
Enanta Pharmaceuticals, Inc
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 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. This includes agents administered during clinical trial participation. Part 2 (HBV 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 70 years, inclusive * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety measured by adverse events | Up to 8 Days in HV SAD Cohorts |
Secondary
| Measure | Time frame |
|---|---|
| Cmax of EDP-514 | Up to 6 Days in HV SAD Cohorts |
| AUC of EDP-514 | Up to 6 Days in HV SAD Cohorts |
Countries
Canada, United States
Outcome results
None listed