NCT04470388 is a Phase 1 clinical trial of EDP-514 in Chronic HBV Infection, sponsored by Enanta Pharmaceuticals, Inc.

Who is sponsoring NCT04470388?

NCT04470388 is sponsored by Enanta Pharmaceuticals, Inc.

What drugs are being tested in NCT04470388?

Interventions in NCT04470388: EDP-514, Placebo.

What condition does NCT04470388 study?

NCT04470388 studies Chronic HBV Infection.

Is NCT04470388 still recruiting?

NCT04470388 is currently completed. Last updated 11 January 2022.

Last reviewed 2022-01-11 · How we verify

NCT04470388

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 Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment

Completed Phase 1 Last updated 11 January 2022

What this trial tests

Phase 1 trial testing EDP-514 in Chronic HBV Infection in 25 participants. Completed in 30 August 2021.

Timeline

9 September 2020

Primary endpoint
30 August 2021

30 August 2021

Quick facts

Lead sponsor	Enanta Pharmaceuticals, Inc
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	triple
Primary purpose	treatment
Enrollment	25
Start date	9 September 2020
Primary completion	30 August 2021
Estimated completion	30 August 2021
Sites	10 locations across Hong Kong, Taiwan

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

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.

Publications & conference data

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

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
Toward a new era of hepatitis B virus therapeutics: The pursuit of a functional cure.
Tsounis EP, Tourkochristou E, Mouzaki A, Triantos C. · · 2021 · cited 33× · PMID 34135551 · DOI 10.3748/wjg.v27.i21.2727
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
Moving Fast Toward Hepatitis B Virus Elimination.
Bassit L, Ono SK, Schinazi RF. · · 2021 · cited 13× · PMID 34258739 · DOI 10.1007/978-981-16-0267-2_5
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
Phase 1 trial of the safety, pharmacokinetics, and antiviral activity of EDP-514 in untreated viremic chronic hepatitis B patients.
Yuen MF, Chuang WL, Peng CY, Jeng WJ, et al · · 2024 · cited 4× · PMID 38528825 · DOI 10.3350/cmh.2023.0535

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
NCT04008004 — A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2) · 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 NCT04470388 (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/NCT04470388.

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