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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04470388

Enrollment

Registered

2020-07-14

Start date

2020-09-09

Completion date

2021-08-30

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic HBV Infection

Keywords

Multiple Ascending Dose, hepatitis B virus, HBV

Brief summary

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.

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.

Interventions

DRUGEDP-514

Oral Capsule

DRUGPlacebo

Placebo to match EDP-514

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
Safety measured by adverse events	Up to 84 Days in HBV MAD Cohorts

Secondary

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

Countries

Hong Kong, Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026