NCT04008004

Brief Summary

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 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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2019

Typical duration for phase_1

Geographic Reach
2 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 26, 2019

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 14, 2021

Completed
Last Updated

January 11, 2022

Status Verified

May 1, 2021

Enrollment Period

2.1 years

First QC Date

July 2, 2019

Last Update Submit

January 6, 2022

Conditions

Chronic HBV Infection

Keywords

"First-in-Human"Single Ascending DoseMultiple Ascending Dosehepatitis B virusHBV

Outcome Measures

Primary Outcomes (3)

  • Safety measured by adverse events

    Up to 8 Days in HV SAD Cohorts

  • Safety measured by adverse events

    Up to 21 Days in HV MAD Cohorts

  • Safety measured by adverse events

    Up to 56 Days in HBV MAD Cohorts

Secondary Outcomes (6)

  • Cmax of EDP-514

    Up to 6 Days in HV SAD Cohorts

  • AUC of EDP-514

    Up to 6 Days in HV SAD Cohorts

  • Cmax of EDP-514

    Up to 18 Days in HV MAD Cohorts

  • AUC of EDP-514

    Up to 18 Days in HV MAD Cohorts

  • Cmax of EDP-514

    Up to 28 Days in HBV MAD Cohorts

  • +1 more secondary outcomes

Study Arms (6)

EDP-514 HV SAD Cohorts

EXPERIMENTAL

EDP-514 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 orally, once daily in one single administration

Drug: EDP-514

EDP-514 HV MAD Cohorts

EXPERIMENTAL

EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 14 days

Drug: EDP-514

EDP-514 HV SAD Placebo Cohort

PLACEBO COMPARATOR

Matching placebo, orally, once daily in one single administration

Drug: Placebo

EDP-514 HV MAD Placebo Cohort

PLACEBO COMPARATOR

Matching placebo, orally, once daily for 14 days

Drug: Placebo

EDP-514 HBV MAD Cohorts

EXPERIMENTAL

EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days

Drug: EDP-514

EDP-514 HBV MAD Placebo Cohort

PLACEBO COMPARATOR

Matching placebo, orally, once daily for 28 days

Drug: Placebo

Interventions

EDP-514DRUG

Oral Capsule; Subjects will receive either a single dose of EDP-514 on Day 1 only (SAD HV), once daily dosing of EDP-514 starting on Day 1 through Day 14 (MAD HV) or once daily dosing of EDP-514 starting on Day 1 through Day 28 (MAD HBV).

EDP-514 HBV MAD CohortsEDP-514 HV MAD CohortsEDP-514 HV SAD Cohorts
PlaceboDRUG

Placebo to match EDP-514

EDP-514 HBV MAD Placebo CohortEDP-514 HV MAD Placebo CohortEDP-514 HV SAD Placebo Cohort

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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):
  • 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 \<LLOQ and
  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Southern California GI and Liver Centers

Coronado, California, 92118, United States

Location

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Tuan Nguyen Md Gastroenterology & Hepatology (Tuan Nguyen, M.D., Inc.)

San Diego, California, 92105, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Pharmaceutical Research Associates, Inc.

Lenexa, Kansas, 66219, United States

Location

Digestive Disease Associates - Catonsville

Catonsville, Maryland, 21228, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

American Research Corporation

Houston, Texas, 77030, United States

Location

The Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

Swedish Organ Transplant and Liver Center

Seattle, Washington, 98104, United States

Location

University Of Calgary

Calgary, Alberta, T2N 4Z6, Canada

Location

Gastroenterology Institute of Research Institute

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

Location

Centre Hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 0A9, Canada

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Enanta Pharmaceuticals, Inc

    Enanta Pharmaceuticals, Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 5, 2019

Study Start

June 26, 2019

Primary Completion

July 14, 2021

Study Completion

July 14, 2021

Last Updated

January 11, 2022

Record last verified: 2021-05

Locations

CA(4)US(11)