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
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
- lead INDUSTRY
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
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