A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)

Enanta Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Chronic HBV Infection

Treatments: Drug: Placebo; Drug: EDP-514

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04008004

EDP 514-001

Details and patient eligibility

About

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

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Exclusion Criteria:

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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99 participants in 6 patient groups, including a placebo group

EDP-514 HV SAD Cohorts

Experimental group

Description:

EDP-514 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 orally, once daily in one single administration

Treatment:

Drug: EDP-514

EDP-514 HV MAD Cohorts

Experimental group

Description:

EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 14 days

Treatment:

Drug: EDP-514

EDP-514 HV SAD Placebo Cohort

Placebo Comparator group

Description:

Matching placebo, orally, once daily in one single administration

Treatment:

Drug: Placebo

EDP-514 HV MAD Placebo Cohort

Placebo Comparator group

Description:

Matching placebo, orally, once daily for 14 days

Treatment:

Drug: Placebo

EDP-514 HBV MAD Cohorts

Experimental group

Description:

EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days

Treatment:

Drug: EDP-514

EDP-514 HBV MAD Placebo Cohort

Placebo Comparator group

Description:

Matching placebo, orally, once daily for 28 days

Treatment:

Drug: Placebo