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

NCT02431312 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2019-10-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

BIOLOGICAL

INO-1800

INO-1800 delivered by EP

BIOLOGICAL

INO-9112

INO-9112 delivered by EP

DRUG

Nucleos(t)ide Analogue Treatment

Continued treatment with nucleos(t)ide analogue

Sponsors & Collaborators

Principal Investigators

  • ShuPing Yang, MD, PhD · Inovio Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-12
Primary Completion
2018-05-22
Completion
2018-05-22

Countries

  • United States
  • Australia
  • Hong Kong
  • New Zealand
  • Philippines
  • Singapore
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02431312 on ClinicalTrials.gov