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Clinical Trials List

Protocol NumberEDP 514-002
NCT Number(ClinicalTrials.gov Identfier)NCT04008004

2020-02-01 - 2021-01-31

Phase I

Recruiting3

Terminated7

ICD-10B18.1

Chronic viral hepatitis B without delta-agent

ICD-9070.32

Viral hepatitis B without mention of hepatic coma, chronic, without mention of hepatitis delta

A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of EDP 514 in Healthy Subjects (Part 1), and Antiviral Activity in Nucleos(t)Ide Reverse Transcriptase Inhibitor (NUC)-Suppressed Patients With Chronic Hepatitis B Virus Infection (Part 2)

  • Trial Applicant

    Pharmaceutical Research Associates Taiwan Inc.

  • Sponsor

    Enanta Pharmaceuticals, Inc.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator PEI-JER CHEN Digestive System Department
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蘇維文 Digestive System Department
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wen-Juei Jeng Digestive System Department
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳啟益 Digestive System Department
Chia-Yi Christian Hosptal

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 許耀峻 Digestive System Department
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 許耀峻 Digestive System Department
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 陳建宏 Digestive System Department
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Ting-Tsung Chang Digestive System Department
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Cheng-Yuan Peng Digestive System Department
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Wan-Long Chuang Digestive System Department
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Chronic hepatitis B virus (CHB) infection

Objectives

Part 1 is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-514 in healthy adult subjects. Part 1 consists of two phases planned in healthy subjects: The first phase assesses single ascending doses for EDP-514 (active drug or placebo) in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect. The second phase assesses multiple ascending doses (active drug or placebo) for 14 days in healthy subjects. Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-514 or placebo. Part 2 is randomized, double -blind, placebo-controlled study including subjects with Hepatitis B Virus. It will assess the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days of orally administered doses of EDP-514 in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection Part 2 assesses multiple ascending doses EDP-514 (active drug or placebo) for 28 days in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection. Each cohort in Part 2 will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo.

Test Drug

EDP 514

Active Ingredient

EDP 514

Dosage Form

Capsule

Dosage

50mg, 100mg, 200mg

Endpoints

Primary Outcome Measures :
Safety measured by adverse events [ Time Frame: Up to 8 Days in HV SAD Cohorts ]
Safety measured by adverse events [ Time Frame: Up to 21 Days in HV MAD Cohorts ]
Safety measured by adverse events [ Time Frame: Up to 56 Days in HBV MAD Cohorts ]

Secondary Outcome Measures :
Cmax of EDP-514 [ Time Frame: Up to 6 Days in HV SAD Cohorts ]
AUC of EDP-514 [ Time Frame: Up to 6 Days in HV SAD Cohorts ]
Cmax of EDP-514 [ Time Frame: Up to 18 Days in HV MAD Cohorts ]
AUC of EDP-514 [ Time Frame: Up to 18 Days in HV MAD Cohorts ]
Cmax of EDP-514 [ Time Frame: Up to 28 Days in HBV MAD Cohorts ]
AUC of EDP-514 [ Time Frame: Up to 28 Days in HBV MAD Cohorts ]

Inclution Criteria

Part 1 (HV Population):

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 65 years, inclusive.

Part 2 (HBV Population):

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:

A Screening HBV DNA level in serum/plasma that is No HBV DNA serum/plasma test values ≥LLOQ over the previous 12 months (using an approved test)
CHB subjects must have been on their prescribed HBV NUC treatment with no change in regimen for 12 months prior to Screening

Exclusion Criteria

Part 1 (HV Population):
Exclusion Criteria:

Clinically relevant evidence or history of illness or disease.
Pregnant or nursing females.
History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
A positive urine drug screen at screening or Day -1.
Current tobacco smokers or use of tobacco within 3 months prior to screening.
Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
History of regular alcohol consumption.
Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose. This includes agents administered during clinical trial participation.

Part 2 (HBV Population):

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

The Estimated Number of Participants

  • Taiwan

    16 participants

  • Global

    24 participants

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