Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
GLS-5300 · 2 trials · 1 indication
Incidence of Adverse events by System organ class (SOC); preferred term (PT); severity and relationship to study treatment and schedule
Administration (injection) site reactions described by frequency
Number of participants with changes based on frequency in safety lab parameters in Complete Blood Count and Liver panel tests" or similar.
Administration (injection) site pain as described by Visual Analog Scale (VAS)
| Arm | Type | Description |
|---|---|---|
| GLS-5300 with ID Cellectra electroporation | EXPERIMENTAL | GLS-5300 at 0.3mg DNA/dose |
| GLS-5300 at 0.3mg DNA/dose with ID Cellectra electroporation | EXPERIMENTAL | GLS-5300 at 0.3mg DNA/dose |
| GLS-5300 at 0.6mg DNA/dose (3 dose regimen) | EXPERIMENTAL | GLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation |
| GLS-5300 at 0.6mg DNA/dose (2 dose regimen) | EXPERIMENTAL | GLS-5300 at 0.6mg DNA/dose with ID Cellectra electroporation |
| GLS-5300 | EXPERIMENTAL | GLS-5300 at 0.67 mg DNA/dose |
| GLS-5300 at 2 mg DNA/dose | EXPERIMENTAL | GLS-5300 at 2 mg DNA/dose |
| GLS-5300 at 6 mg DNA/dose | EXPERIMENTAL | GLS-5300 at 6 mg DNA/dose |
| Name | Type | Description |
|---|---|---|
| GLS-5300 | BIOLOGICAL | \[Part A\] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) \[Part B\] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) GLS-5300 0.6 mg at 0, 4, and 12 weeks (N=25) GLS-5300 0.6 mg at 0 and 8 weeks (N=25) |
| Cellectra 2000 Electroporation | DEVICE | GLS-5300 administered ID followed by Cellectra 2000 Electroporation |
Inclusion Criteria: 1. Age 19-70 years; 2. Able to provide consent to participate and having signed an Informed Consent Form (ICF); 3. Able and willing to comply with all study procedures; 4. Women of child-bearing potential agree to either remain sexually abstinent, use medically effective contrac...
GLS-5300 is an investigational monoclonal antibody developed by Inovio Pharmaceuticals, Inc. (ticker INO) that targets the MERS-CoV Spike (S) glycoprotein. It has been studied in Phase 1 clinical trials in healthy volunteers, with two completed trials and no active trials at this time.
GLS-5300 targets the MERS-CoV Spike (S) glycoprotein, a protein on the surface of the Middle East respiratory syndrome coronavirus. By binding to this target, the monoclonal antibody is designed to interfere with the virus's ability to enter host cells.
GLS-5300 is being developed by Inovio Pharmaceuticals, Inc., which trades under the ticker symbol INO. The company has sponsored the clinical trials evaluating the monoclonal antibody in healthy volunteers.
GLS-5300 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and there are currently no active trials. The drug has not been approved by the FDA and remains investigational.
GLS-5300 has been evaluated in two completed Phase 1 trials: NCT03721718, which studied safety, tolerability, and immunogenicity in 60 healthy volunteers in South Korea, and NCT02670187, an open-label dose-ranging safety study in 75 healthy volunteers in the United States.