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

Sponsor

Enanta Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT04470388

Collaborator

Pharmaceutical Research Associates (Other)

Enrollment

Locations

Arms

11.7

Actual Duration (Months)

2.5

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic HBV Infection	Drug: EDP-514 Drug: Placebo	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Sep 9, 2020

Actual Primary Completion Date :

Aug 30, 2021

Actual Study Completion Date :

Aug 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Safety measured by adverse events [Up to 84 Days in HBV MAD Cohorts]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Queen Mary Hospital	Hong Kong	Hong Kong
2	Changhua Christian Hospital	Changhua	Taiwan	500209
3	Chia-Yi Christian Hospital	Chiayi	Taiwan	600566
4	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung	Taiwan	500209
5	E-Da Hospital/E-DA Cancer Hospital	Kaohsiung	Taiwan	824410
6	Kaohsiung Chang Gung Memorial Hospital	Kaohsiung	Taiwan	833401
7	China Medical University Hospital	Taichung	Taiwan	404332
8	National Cheng Kung University Hospital	Tainan	Taiwan	704302
9	National Taiwan University Hospital	Taipei	Taiwan	100229
10	Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch	Taoyuan	Taiwan	333423