A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment

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

NCT04470388

EDP 514-002

Details and patient eligibility

About

This is a randomized, double-blind, placebo-controlled study in viremic chronic hepatitis B subjects, assessing the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days treatment with EDP-514.

Full description

The study assesses multiple ascending doses of EDP-514 compared to placebo for 28 days in viremic chronic CHB-infected subjects not currently on treatment.

Each cohort will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo.

Enrollment: 25 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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:

  • 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 for at least 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: Triple Blind

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25 participants in 2 patient groups, including a placebo group

EDP-514 HBV MAD Cohorts

Experimental group

Description:

EDP-514 capsule 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