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

Phase 1

Completed

• Conditions: Chronic HBV Infection
• Interventions: Drug: Placebo; Drug: EDP-514

• Registration Number: NCT04470388
• Lead Sponsor: Enanta Pharmaceuticals, Inc

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.

Study Timeline

• Study First Submitted: 2020-07-10
• Study First Submitted QC: 2020-07-10
• Study First Posted: 2020-07-14
• Study Start: 2020-09-09
• Primary Completion: 2021-08-30
• Study Completion: 2021-08-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
EDP-514 HBV MAD Placebo Cohort	Placebo	Matching placebo, orally, once daily for 28 days.
EDP-514 HBV MAD Cohorts	EDP-514	EDP-514 capsule Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days.

Primary Outcome Measures

Name	Time	Method
Safety measured by adverse events	Up to 84 Days in HBV MAD Cohorts

Secondary Outcome Measures

Name	Time	Method
AUC of EDP-514	Up to 28 Days in HBV MAD Cohorts
Cmax 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

Trial Locations

Locations (10)

E-Da Hospital/E-DA Cancer Hospital; 🇨🇳 Kaohsiung, Taiwan

Changhua Christian Hospital; 🇨🇳 Changhua, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan

Chia-Yi Christian Hospital; 🇨🇳 Chiayi, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch; 🇨🇳 Taoyuan, Taiwan

Queen Mary Hospital; 🇭🇰 Hong Kong, Hong Kong