NCT02431312 is a Phase 1 clinical trial of INO-1800 in Hepatitis B, sponsored by Inovio Pharmaceuticals.

Who is sponsoring NCT02431312?

NCT02431312 is sponsored by Inovio Pharmaceuticals.

What drugs are being tested in NCT02431312?

Interventions in NCT02431312: INO-1800, INO-9112, Nucleos(t)ide Analogue Treatment.

What condition does NCT02431312 study?

NCT02431312 studies Hepatitis B.

Is NCT02431312 still recruiting?

NCT02431312 is currently completed. Last updated 15 October 2019.

Last reviewed 2019-10-15 · How we verify

NCT02431312

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

Phase I Study of INO-1800 With or Without INO-9112 + EP in Chronic Hepatitis B Subjects

Completed Phase 1 Last updated 15 October 2019

What this trial tests

Phase 1 trial testing INO-1800 in Hepatitis B in 90 participants. Completed in 22 May 2018.

Timeline

12 January 2015

Primary endpoint
22 May 2018

22 May 2018

Quick facts

Lead sponsor	Inovio Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	90
Start date	12 January 2015
Primary completion	22 May 2018
Estimated completion	22 May 2018
Sites	22 locations across Hong Kong, New Zealand, Taiwan, Philippines, Thailand, Australia, Singapore, United States

Drugs / interventions tested

INO-1800 — full drug profile →
INO-9112 — full drug profile →
Nucleos(t)ide Analogue Treatment — full drug profile →

Conditions studied

Hepatitis B — all drugs for Hepatitis B →

Sponsor

Inovio Pharmaceuticals — full company profile →

Who can join

Adults 18 to 65, any sex, with Hepatitis B. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This was an open-label study that evaluated the safety, tolerability, and immunogenicity of dose combinations of INO-1800 (DNA plasmids encoding Hepatitis B surface antigen \[HBsAg\] and Hepatitis B core antigen \[HBcAg\]) and INO-9112 (DNA plasmid encoding human interleukin 12) delivered by electroporation (EP) in 90 (ninety) nucleos(t)ide analogue treated participants.

Publications & conference data

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

Innovation and trends in the development and approval of antiviral medicines: 1987-2017 and beyond.
Chaudhuri S, Symons JA, Deval J. · · 2018 · cited 136× · PMID 29758235 · DOI 10.1016/j.antiviral.2018.05.005
Engineering DNA vaccines against infectious diseases.
Lee J, Arun Kumar S, Jhan YY, Bishop CJ. · · 2018 · cited 125× · PMID 30172933 · DOI 10.1016/j.actbio.2018.08.033
Development of Direct-acting Antiviral and Host-targeting Agents for Treatment of Hepatitis B Virus Infection.
Xia Y, Liang TJ. · · 2019 · cited 91× · PMID 30243618 · DOI 10.1053/j.gastro.2018.07.057
Cytomegalovirus Vaccines: Current Status and Future Prospects.
Anderholm KM, Bierle CJ, Schleiss MR. · · 2016 · cited 85× · PMID 27882457 · DOI 10.1007/s40265-016-0653-5
Hepatitis B Virus Cure: Targets and Future Therapies.
Lee HW, Lee JS, Ahn SH. · · 2020 · cited 75× · PMID 33379331 · DOI 10.3390/ijms22010213
DNA and mRNA vaccination against allergies.
Scheiblhofer S, Thalhamer J, Weiss R. · · 2018 · cited 54× · PMID 30063806 · DOI 10.1111/pai.12964
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

Verify or expand the search:

Other recruiting trials for Hepatitis B

Currently open trials in the same condition.

NCT04843852 — TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B · Phase 1 · recruiting
NCT07168356 — A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease · Phase 1 · recruiting
NCT06947356 — Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads · NA · recruiting
NCT06537414 — A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living Wit · Phase 2 · active not recruiting
NCT06623071 — Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384 · recruiting

Other Inovio Pharmaceuticals trials

Trials by the same sponsor.

NCT04588428 — Safety, Tolerability and Immunogenicity of INO-4700 for MERS-CoV in Healthy Volunteers · Phase 2 · completed
NCT04093076 — Dose-ranging Study: Safety, Tolerability and Immunogenicity of INO-4500 in Healthy Volunteers in Ghana · Phase 1 · completed
NCT04642638 — Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure · Phase 2, PHASE3 · terminated
NCT04398433 — INO-3107 With Electroporation (EP) in Participants With HPV-6- and/or HPV-11-Associated Recurrent Respiratory Papillomat · Phase 1, PHASE2 · completed
NCT04336410 — Safety, Tolerability and Immunogenicity of INO-4800 for COVID-19 in Healthy Volunteers · Phase 1 · 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 NCT02431312 (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 Inovio Pharmaceuticals
Last refreshed: 15 October 2019

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/NCT02431312.

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