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

January 6, 2022 updated by: Enanta Pharmaceuticals, Inc

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
  • Taiwan
      • Changhua, Taiwan, 500209
        • Changhua Christian Hospital
      • Chiayi, Taiwan, 600566
        • Chia-Yi Christian Hospital
      • Kaohsiung, Taiwan, 500209
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Kaohsiung, Taiwan, 824410
        • E-Da Hospital/E-DA Cancer Hospital
      • Kaohsiung, Taiwan, 833401
        • Kaohsiung Chang Gung Memorial Hospital
      • Taichung, Taiwan, 404332
        • China Medical University Hospital
      • Tainan, Taiwan, 704302
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 100229
        • National Taiwan University Hospital
      • Taoyuan, Taiwan, 333423
        • Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EDP-514 HBV MAD Cohorts
EDP-514 capsule Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days.
Drug: EDP-514
Oral Capsule
Placebo Comparator: EDP-514 HBV MAD Placebo Cohort
Matching placebo, orally, once daily for 28 days.
Drug: Placebo
Placebo to match EDP-514

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety measured by adverse events
Time Frame: Up to 84 Days in HBV MAD Cohorts
Up to 84 Days in HBV MAD Cohorts

Secondary Outcome Measures

Outcome Measure
Time Frame
Cmax of EDP-514
Time Frame: Up to 28 Days in HBV MAD Cohorts
Up to 28 Days in HBV MAD Cohorts
AUC of EDP-514
Time Frame: Up to 28 Days in HBV MAD Cohorts
Up to 28 Days in HBV MAD Cohorts
Change from baseline in HBV DNA Viral Load Assay
Time Frame: through Day 28 in HBV MAD Cohorts
through Day 28 in HBV MAD Cohorts

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Enanta Pharmaceuticals, Inc

Collaborators

Pharmaceutical Research Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 9, 2020

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

August 30, 2021

Study Registration Dates

First Submitted

July 10, 2020

First Submitted That Met QC Criteria

July 10, 2020

First Posted (Actual)

July 14, 2020

Study Record Updates

Last Update Posted (Actual)

January 11, 2022

Last Update Submitted That Met QC Criteria

January 6, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDP 514-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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