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GLS-5700

Phase 1

Healthy | Monoclonal antibody | Other |Inovio Pharmaceuticals, Inc.|Last Updated: Dec 24, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment200

FDA Designations

No designations recorded

Clinical trial landscape

GLS-5700 · 2 trials · 2 indications

Phase 1 2
NCT02887482GLS-5700 in Dengue Virus Seropositive AdultsHealthy
COMPLETED160 Analytics
NCT02809443GLS-5700 in Dengue Virus-Naïve AdultsHealthy
COMPLETED40 Analytics
PHASE1COMPLETED
GLS-5700 in Dengue Virus Seropositive Adults
HealthyUnlock trial analytics
PHASE1COMPLETED
GLS-5700 in Dengue Virus-Naïve Adults
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Mean change from baseline in safety laboratory measures
Day 0 through Week 14
Incidence of solicited adverse events after vaccination
Day 0 through Week 14
Incidence of unsolicited adverse events after vaccination
Day 0 through Week 14
Incidence of serious adverse events
Day 0 through Week 14
Number of Participants With Serious Adverse Events From Day 0 Through Week 60
Day 0 through Week 60

Secondary Endpoints

Binding antibody titers to Zika envelope
Day 0 through Week 60 following first dose
Neutralizing antibody response against Zika virus
Day 0 through Week 60 following first dose
T cell response
Day 0 through Week 60 following first dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboEXPERIMENTALPlacebo at 0 mg DNA/dose
GLS-5700EXPERIMENTALGLS 5700 at 2 mg DNA/dose. GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
GLS-5700 at 1 mgEXPERIMENTALDNA/dose
GLS-5700 at 2 mgEXPERIMENTALDNA/dose

Interventions

NameTypeDescription
GLS-5700BIOLOGICALGLS 5700 at 2 mg DNA/dose
PlaceboBIOLOGICAL -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites3

Inclusion Criteria: * Age 18-65 years; * Able to provide consent to participate and having signed an Informed Consent Form (ICF); * Able and willing to comply with all study procedures; * Women of child-bearing potential agree to use medically effective contraception (oral contraception, barrier me...

Countries:Puerto RicoUnited StatesCanada
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Frequently asked questions about GLS-5700

What is GLS-5700 used for?

GLS-5700 is an investigational monoclonal antibody being studied in healthy adults for the prevention of dengue virus and Zika virus infections. It is currently in Phase 1 clinical development and is not yet approved by the FDA.

Who makes GLS-5700?

GLS-5700 is being developed by Inovio Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol INO. The company is conducting clinical trials to evaluate the safety and immunogenicity of this investigational product.

What phase is GLS-5700 in?

GLS-5700 is in Phase 1 clinical development. Two Phase 1 trials have been completed, one in dengue virus-naïve adults and one in dengue virus seropositive adults. The drug is still investigational and has not received regulatory approval.

What clinical trials is GLS-5700 in?

GLS-5700 has been studied in two completed Phase 1 trials. NCT02809443 enrolled 40 healthy adults in the United States and Canada, while NCT02887482 enrolled 160 healthy adults in Puerto Rico. Both trials were randomized, double-blind, and controlled.

How does GLS-5700 work?

GLS-5700 is a monoclonal antibody designed to target and neutralize dengue virus and Zika virus. By binding to viral proteins, it may prevent the viruses from infecting human cells, potentially offering protection against these mosquito-borne diseases.