drugset / Trial / NCT00513968

Phase I Study to Investigate the Safety and Efficacy of HBV DNA Vaccine

NCT00513968

Phase 1 Completed 27 enrolled Genexine, Inc.
RandomizedParallel-groupOpen-labelTreatment

Summary

This study will evaluate the safety and immunogenicity of a novel mixed plasmid DNA (HB-110) combined with an antiviral agent (Adefovir) for the patients with chronic Hepatitis B infection.

Timeline

Start
2007-07
Primary completion
2010-04
Completion
2010-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adefovir Unknown 10 mg Oral
Subject HB-110 Vaccine 2 mg Intramuscular
Subject HB-110 Vaccine 4 mg Intramuscular
Subject HB-110 Vaccine 8 mg Intramuscular