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VGX-3400 · 1 trial · 1 indication
Frequency, severity of local and systemic reactogenicity signs and symptoms, adverse events and serious adverse events
| Arm | Type | Description |
|---|---|---|
| 0.6mg DNA/dose | EXPERIMENTAL | Subjects will receive a 2 dose series of VGX-3400 containing 0.6mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1 |
| 2mg DNA/dose | EXPERIMENTAL | Subjects will receive a 2 dose series of VGX-3400 containing 2mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1 |
| 6mg DNA/dose | EXPERIMENTAL | Subjects will receive a 2 dose series of VGX-3400 containing 6mg DNA/dose administered via IM injection + electroporation at Day 0 and Month 1 |
| Name | Type | Description |
|---|---|---|
| VGX-3400 | BIOLOGICAL | Plasmid DNA delivered via IM injection with electroporation |
Inclusion Criteria: * Written informed consent in accordance with institutional guidelines. If required by local law, candidates must also authorize the release and use of protected health information (PHI) * Male subjects 20-39 years of age * Healthy subjects as judged by the Investigator based on...
VGX-3400 is an investigational monoclonal antibody developed by Inovio Pharmaceuticals, Inc. It is a plasmid DNA-based product designed for use with an electroporation device. It has been studied in healthy adult male volunteers in a Phase 1 clinical trial conducted in South Korea.
VGX-3400 was studied for use against H5N1 avian flu virus. The Phase 1 trial was titled Study Of VGX-3400, H5N1 Avian Flu Virus Plasmid DNA With Electroporation Device In Healthy Adult Males. The study enrolled healthy volunteers rather than patients with an active infection.
VGX-3400 is developed by Inovio Pharmaceuticals, Inc., which trades under the ticker INO. Inovio is the sponsor of the clinical program for this monoclonal antibody asset.
VGX-3400 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, and no trials are currently active.
VGX-3400 has been evaluated in one completed Phase 1 trial, NCT01184976, titled Study Of VGX-3400, H5N1 Avian Flu Virus Plasmid DNA With Electroporation Device In Healthy Adult Males. The trial enrolled 30 healthy adult males aged 20 years and older in South Korea and used a controlled design.