drugset / Trial / NCT02431312
Phase I Study of INO-1800 With or Without INO-9112 + EP in Chronic Hepatitis B Subjects
RandomizedFactorialOpen-labelTreatment
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.
Timeline
- Start
- 2015-01-12
- Primary completion
- 2018-05-22
- Completion
- 2018-05-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | INO-1800 | Vaccine | 0.3 mg | Intramuscular |
| Subject | INO-1800 | Vaccine | 2 mg | Intramuscular |
| Subject | INO-1800 | Vaccine | 9 mg | Intramuscular |
| Subject | INO-9112 | Unknown | 0.25 mg | Intramuscular |