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VGX-6150

Phase 1

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

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

VGX-6150 is an investigational monoclonal antibody being developed for the treatment of chronic Hepatitis C infection. It is intended as a second-line therapy for patients with this condition. The drug is currently in clinical development and has not been approved by regulatory authorities.

What does VGX-6150 target?

VGX-6150 is a monoclonal antibody, but its specific molecular target has not been disclosed in available information. The drug is being studied for its safety, tolerability, and immunogenicity in patients with chronic Hepatitis C, indicating it may modulate immune responses, though the exact mechanism remains unspecified.

Who makes VGX-6150?

VGX-6150 is being developed by Inovio Pharmaceuticals, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol INO. The company is conducting clinical research on this investigational monoclonal antibody for chronic Hepatitis C.

What phase is VGX-6150 in?

VGX-6150 is in Phase 1 clinical development. A Phase 1 trial has been completed, evaluating the safety, tolerability, and immunogenicity of the drug as a second-line therapy for chronic Hepatitis C. The drug remains investigational and is not yet approved for commercial use.

What clinical trials is VGX-6150 in?

VGX-6150 has been studied in one clinical trial, identified as NCT02027116. This Phase 1 trial, titled 'Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Second-line Therapy of Chronic Hepatitis C Infection,' was completed in South Korea with 18 participants.

Is VGX-6150 the same as any other drug?

No alternative names for VGX-6150 have been identified. The drug is known by its code name VGX-6150 and is being developed by Inovio Pharmaceuticals. It is a distinct investigational monoclonal antibody candidate for chronic Hepatitis C.