Trials / Completed
CompletedNCT02431312
Phase I Study of INO-1800 With or Without INO-9112 + EP in Chronic Hepatitis B Subjects
Phase I, Randomized, Open-Label, Active-Controlled, Dose Escalation Study to Evaluate the Safety, Tolerability & Immunogenicity of INO-1800 Alone or in Combination With INO-9112 Delivered IM Followed by EP in Select Nucleos(t)Ide Analogue-Treated, Chronic Hepatitis B Patients
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 90 (actual)
- Sponsor
- Inovio Pharmaceuticals · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2015-01-12
- Primary completion
- 2018-05-22
- Completion
- 2018-05-22
- First posted
- 2015-05-01
- Last updated
- 2019-10-15
Locations
22 sites across 8 countries: United States, Australia, Hong Kong, New Zealand, Philippines, Singapore, Taiwan, Thailand
Source: ClinicalTrials.gov record NCT02431312. Inclusion in this directory is not an endorsement.