drugset / Trial / NCT01641536

Tolerability, Immunogenicity and Efficacy of HB-110 Administered by Electroporation in Chronic Hepatitis B Patients

NCT01641536

Phase 1 Completed 9 enrolled Genexine, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

This study is an open label, dose escalation study using the classical 3+3 design to determine the MTD of HB-110 and assess the safety, immunogenicity and efficacy of HB-110 DNA therapeutic vaccine administered by Electroporation in combination with Entecavir in chronic hepatitis B patients.

Timeline

Start
2011-11
Primary completion
2012-12
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Subject HB-110 Vaccine 1 mg Other
Subject HB-110 Vaccine 2 mg Other
Subject HB-110 Vaccine 4 mg Other
Background Entecavir Small molecule 0.5 mg Oral