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GLS-6150

Phase 1

HCV Infection | Monoclonal antibody | Infectious Disease |Inovio Pharmaceuticals, Inc.|Last Updated: May 27, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

GLS-6150 · 1 trial · 1 indication

Phase 1 1
NCT03674125Evaluation of Safety, Tolerability, and Immunogenicity Study of GLS-6150 in Healthy Volunteers and in Persons Previously Treated for Hepatitis C Virus InfectionHCV Infection
COMPLETED32 Analytics
PHASE1COMPLETED
Evaluation of Safety, Tolerability, and Immunogenicity Study of GLS-6150 in Healthy Volunteers and in Persons Previously Treated for Hepatitis C Virus Infection
HCV InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events
Day0 through up to 28 weeks
Administration (injection) site reactions
Day0 through up to 28 weeks
Changes in safety laboratory parameters described by frequency and severity grade
Day0 through up to 28 weeks

Secondary Endpoints

Antigen specific cellular immune responses to Hepatitis C virus as determined by Interferon-gamma (IFN-γ) ELISpot and/or FACS assay
Day0 through up to 28 weeks
Binding antibody titers to the HCV non-structural proteins (NS3, NS4, NS5) measured by ELISA
Day0 through up to 28 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTALGLS-6150 at 2.0 mg DNA/dose (3 dose prime plus boost)
Group 2EXPERIMENTALGLS-6150 at 1.0 mg DNA/dose (3 dose prime plus boost)
Group 3EXPERIMENTALGLS-6150 at 2.0 mg DNA/dose(3 dose prime plus boost)
Group 4EXPERIMENTALGLS-6150 at 2.0 mg DNA/dose(2 dose prime plus boost)

Interventions

NameTypeDescription
GLS-6150BIOLOGICALGroup 1: GLS-6150 2.0 mg at 0, 4, 12, and 24 weeks (N=8, healthy volunteers); Group 2: GLS-6150 1.0 mg at 0, 4, 12, and 24 weeks (N=8, previously treated for HCV infection); Group 3: GLS-6150 2.0 mg at 0, 4, 12, and 24 weeks (N=8, previously treated for HCV infection); Group 4: GLS-6150 2.0 mg at 0, 8, and 24 weeks (N=8, previously treated for HCV infection)
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Eligibility Criteria

Age Range19 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: 1. Age 19-65 years; 2. HCV seronegative (Group 1 only), HCV seropositive (Groups 2, 3, 4 only) 3. Prior treatment for genotype 1a or 1b Hepatitis C infection with treatment ending (12 weeks after end of DAA treatment, 24 weeks after end of combination treatment with Ribavirin/In...

Countries:South Korea
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Frequently asked questions about GLS-6150

What is GLS-6150 used for?

GLS-6150 is an investigational monoclonal antibody being developed for the treatment of HCV Infection, a viral infection of the liver. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes GLS-6150?

GLS-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 trials to evaluate the safety and immunogenicity of this investigational drug.

What phase is GLS-6150 in?

GLS-6150 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved for commercial use. The Phase 1 trial has been completed, and the drug remains under clinical investigation for HCV Infection.

What clinical trials is GLS-6150 in?

GLS-6150 has one completed Phase 1 clinical trial, identified as NCT03674125. This study evaluated the safety, tolerability, and immunogenicity of GLS-6150 in healthy volunteers and in persons previously treated for Hepatitis C Virus infection. The trial enrolled 32 participants in South Korea.

Is GLS-6150 the same as any other drug?

GLS-6150 is a distinct investigational monoclonal antibody developed by Inovio Pharmaceuticals. No alternative names for this drug have been disclosed in the clinical trial information. It is being studied specifically for its potential role in treating HCV Infection.