NCT04008004 is a Phase 1 clinical trial of EDP-514 in Chronic HBV Infection, sponsored by Enanta Pharmaceuticals, Inc.

Who is sponsoring NCT04008004?

NCT04008004 is sponsored by Enanta Pharmaceuticals, Inc.

What drugs are being tested in NCT04008004?

Interventions in NCT04008004: EDP-514, Placebo.

What condition does NCT04008004 study?

NCT04008004 studies Chronic HBV Infection.

Is NCT04008004 still recruiting?

NCT04008004 is currently completed. Last updated 11 January 2022.

Last reviewed 2022-01-11 · How we verify

NCT04008004

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)

Completed Phase 1 Last updated 11 January 2022

What this trial tests

Phase 1 trial testing EDP-514 in Chronic HBV Infection in 99 participants. Completed in 14 July 2021.

Timeline

26 June 2019

Primary endpoint
14 July 2021

14 July 2021

Quick facts

Lead sponsor	Enanta Pharmaceuticals, Inc
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	99
Start date	26 June 2019
Primary completion	14 July 2021
Estimated completion	14 July 2021
Sites	15 locations across Canada, United States

Drugs / interventions tested

EDP-514 — full drug profile →
Placebo

Conditions studied

Chronic HBV Infection — all drugs for Chronic HBV Infection →

Sponsor

Enanta Pharmaceuticals, Inc — full company profile →

Who can join

Adults 18 to 70, any sex, with Chronic HBV Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Toward a complete cure for chronic hepatitis B: Novel therapeutic targets for hepatitis B virus.
Kim SW, Yoon JS, Lee M, Cho Y. · · 2022 · cited 53× · PMID 34281294 · DOI 10.3350/cmh.2021.0093
New Approaches to the Treatment of Chronic Hepatitis B.
Alexopoulou A, Vasilieva L, Karayiannis P. · · 2020 · cited 50× · PMID 33019573 · DOI 10.3390/jcm9103187
The progress of molecules and strategies for the treatment of HBV infection.
Pan Y, Xia H, He Y, Zeng S, et al · · 2023 · cited 33× · PMID 37009498 · DOI 10.3389/fcimb.2023.1128807
The Hepatitis B Virus Nucleocapsid-Dynamic Compartment for Infectious Virus Production and New Antiviral Target.
Niklasch M, Zimmermann P, Nassal M. · · 2021 · cited 30× · PMID 34829806 · DOI 10.3390/biomedicines9111577
Novel Antivirals in Clinical Development for Chronic Hepatitis B Infection.
Mak LY, Seto WK, Yuen MF. · · 2021 · cited 20× · PMID 34207458 · DOI 10.3390/v13061169
The premise of capsid assembly modulators towards eliminating HBV persistence.
Bassit L, Amblard F, Patel D, Biteau N, et al · · 2023 · cited 19× · PMID 37477111 · DOI 10.1080/17460441.2023.2239701
Current trends and advances in antiviral therapy for chronic hepatitis B.
Li J, Liu S, Zang Q, Yang R, et al · · 2024 · cited 7× · PMID 38945693 · DOI 10.1097/cm9.0000000000003178
Therapeutic advances in HBV cure.
Hui RW, Mak LY, Seto WK, Yuen MF. · · 2024 · cited 3× · PMID 38623151 · DOI 10.1097/cld.0000000000000161

Verify or expand the search:

Other trials of EDP-514

Trials testing the same drug.

NCT04971512 — A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC H · Phase 1 · terminated
NCT04783753 — Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects · Phase 1 · completed
NCT04470388 — A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment · Phase 1 · completed

Other Enanta Pharmaceuticals, Inc trials

Trials by the same sponsor.

NCT06917508 — A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participa · Phase 1 · completed
NCT06847464 — A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the P · Phase 1 · completed
NCT06601192 — A Study to Investigate the Effects of Zelicapavir (EDP-938) on QTc Interval in Healthy Adults · Phase 1 · completed
NCT06170242 — A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus · Phase 2 · completed
NCT05568706 — A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications. · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04008004 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Enanta Pharmaceuticals, Inc
Last refreshed: 11 January 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04008004.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing