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 drug being studied in healthy volunteers. It is being evaluated for safety, tolerability, and immunogenicity in Phase 1 clinical trials. The drug is not approved for any indication and remains in clinical development.
GLS-5300 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 drug's safety and immunogenicity in healthy volunteers.
GLS-5300 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 135 participants enrolled. The drug is investigational and has not been approved by regulatory authorities.
GLS-5300 has been studied in two completed Phase 1 trials. NCT02670187 enrolled 75 healthy volunteers in the United States, and NCT03721718 enrolled 60 healthy volunteers in South Korea. Both trials assessed safety, tolerability, and immunogenicity.
GLS-5300 is not FDA approved. It is an investigational drug that has completed Phase 1 clinical trials in healthy volunteers. The drug remains in clinical development and has not been authorized for any medical use.