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NCT Number: NCT04470388

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

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.

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Key information

Conditions

Chronic HBV Infection Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Queen Mary Hospital, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EDP-514

Drug

Oral Capsule

Placebo

Drug

Placebo to match EDP-514

Primary outcomes

  1. Safety measured by adverse events

    Time frame: Up to 84 Days in HBV MAD Cohorts

Secondary outcomes

  1. Cmax of EDP-514

    Time frame: Up to 28 Days in HBV MAD Cohorts

  2. AUC of EDP-514

    Time frame: Up to 28 Days in HBV MAD Cohorts

  3. Change from baseline in HBV DNA Viral Load Assay

    Time frame: through Day 28 in HBV MAD Cohorts

Sponsors and collaborators

Lead sponsor

Enanta Pharmaceuticals, Inc

Industry

Collaborators

  • Pharmaceutical Research Associates

Registry information

Official study title

A Phase 1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of EDP 514 in Viremic Chronic Hepatitis B Virus Infected Patients Not Currently on Treatment

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 14, 2020
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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