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Keep this study
Lead
Enanta Pharmaceuticals, Inc
With
Pharmaceutical Research Associates
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.
Age
18–70
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Part 1 (HV 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 65 years, inclusive.
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
You may not be if
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):
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
Clareo Health | A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)
