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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Chronic HBV Infection

Intervention / Treatment
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* Drug: EDP-514
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Ascending Dose, hepatitis B virus, HBV