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VGX-6150

Phase 1

Hepatitis C, Chronic | Monoclonal antibody | Infectious Disease |Inovio Pharmaceuticals, Inc.|Trials Updated: Aug 7, 2017

VGX-6150 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2001

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

VGX-6150 clinical trials

VGX-6150 · 1 trial · 1 indication

Phase 1 1
NCT02027116Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Second-line Therapy of Chronic Hepatitis C InfectionHepatitis C, Chronic
COMPLETED18 Analytics
PHASE1COMPLETED
Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Second-line Therapy of Chronic Hepatitis C Infection
Hepatitis C, ChronicUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability
Screening ~ week 36

To evaluate the safety and tolerability of VGX-6150 as second-line therapy in chronic hepatitis C patients.

Secondary Endpoints

Immunogenicity and virologic response
Screening ~ Week 36
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Experimental: 1mg of DNA/doseEXPERIMENTALSubjects will receive a 3 dose series of VGX-6150 containing 1mg DNA/dose administered via IM injection + electroporation at Day 0, Week 4, Week 8, Week 12
Experimental: 3mg of DNA/doseEXPERIMENTALSubjects will receive a 3 dose series of VGX-6150 containing 3mg DNA/dose administered via IM injection + electroporation at Day 0, Week 4, Week 8, Week 12
Experimental: 6mg of DNA/doseEXPERIMENTALSubjects will receive a 3 dose series of VGX-6150 containing 6mg DNA/dose administered via IM injection + electroporation at Day 0, Week 4, Week 8, Week 12

Interventions

NameTypeDescription
VGX-6150BIOLOGICALPlasmid DNA delivered via IM injection with electroporation
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Eligibility Criteria

Age Range19 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Subjects who want to participate in this trial should meet all of the following criteria. 1. Male or females aged 19 to 65 years 2. Chronic hepatitis C patients infected with HCV genotype 1a or 1b 3. Patients who failed\* SOC therapy with PEG-IFN and ribavirin or triple...

Countries:South Korea
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Frequently asked questions about VGX-6150

What is VGX-6150?

VGX-6150 is an investigational monoclonal antibody developed by Inovio Pharmaceuticals, Inc. for chronic Hepatitis C infection. It was studied as a second-line therapy for patients with chronic Hepatitis C. The candidate has completed a single Phase 1 clinical trial and remains in clinical development.

What is VGX-6150 used for in chronic Hepatitis C?

VGX-6150 was developed for second-line therapy of chronic Hepatitis C infection, meaning treatment of patients who had already received prior therapy. It is an investigational monoclonal antibody and is not an approved treatment. Its only clinical study enrolled 18 patients with chronic Hepatitis C in South Korea.

Who makes VGX-6150?

VGX-6150 is developed by Inovio Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker INO. Inovio is the sponsor of the clinical program evaluating the monoclonal antibody in chronic Hepatitis C infection.

What phase is VGX-6150 in?

VGX-6150 is in Phase 1 development. Its single clinical trial, a Phase 1 study in chronic Hepatitis C, has been completed, and no active trials are currently listed. The drug is investigational and has not been approved for any indication.

What clinical trials is VGX-6150 in?

VGX-6150 has been studied in one clinical trial, NCT02027116, titled a Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Second-line Therapy of Chronic Hepatitis C Infection. The trial was completed, enrolled 18 participants, and was conducted in South Korea.