Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INO-4800 · 2 trials · 2 indications
* Percentage of participants with seroconversion of SARS-CoV-2 Spike glycoprotein antigen-specific antibody titers from baseline by binding assays \[Immunogenicity\] * Incidence of adverse events among participants during the study period \[Safety and Tolerability\] * Percentage of Participants with Administration (Injection) Site Reactions \[Safety and Tolerability\] * Incidence of Adverse Events of Special Interest (AESIs) among participants during the study period \[Safety and Tolerability\]
| Arm | Type | Description |
|---|---|---|
| Group 1 (Part A) | EXPERIMENTAL | * Number of Subjects: 20 subjects * ID Injection of INO-4800 1mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4) |
| Group 2 (Part A) | EXPERIMENTAL | * Number of Subjects: 20 subjects * ID Injection of INO-4800 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4) |
| Group 3 (Part B) | EXPERIMENTAL | * Number of Subjects: 90 subjects * ID Injection of INO-4800 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4) |
| Group 4 (Part B, Placebo) | PLACEBO_COMPARATOR | * Number of Subjects: 30 subjects * ID Injection of Placebo (SSC) 1mg or 2mg/dose + EP using CELLECTRA® 2000 (dosing at Day 0 and Week 4) |
| Group 1: INO-4800 | EXPERIMENTAL | Participants will receive one ID injection of 1.0 milligram (mg) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit. |
| Group 2: INO-4800 | EXPERIMENTAL | Participants will receive two ID injections of 1.0 mg (total 2.0 mg per dosing visit) of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit. |
| Group 3: INO-4800 | EXPERIMENTAL | Participants will receive one ID injection of 0.5 mg of INO-4800 followed by EP using the CELLECTRA® 2000 device per dosing visit. |
| Name | Type | Description |
|---|---|---|
| INO-4800 | BIOLOGICAL | \- Manufacturer: Inovio Pharmaceuticals Inc. |
| CELLECTRA® 2000 | DEVICE | \- Manufacturer: Inovio Pharmaceuticals Inc. |
| Saline-sodium citrate (SSC) buffer | OTHER | \- Manufacturer: Inovio Pharmaceuticals Inc. |
Inclusion Criteria: * Able to communicate with investigator, and to provide informed consent and have signed Informed Consent Form (ICF) prior to screening procedures * Adults aged 19 to 50 years (for Part A) or aged 19 to 64 (for Part B) * Judged to be healthy by the Investigator on the basis of m...
INO-4800 is an investigational drug being developed for the prevention of coronavirus infection, including COVID-19. It is a small molecule being studied in healthy volunteers to evaluate its safety, tolerability, and immunogenicity. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
INO-4800 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 immune response in healthy volunteers for the prevention of coronavirus infection.
INO-4800 is in Phase 1 clinical development. Two Phase 1 trials have been completed, with a total of 199 participants enrolled. The drug is investigational and has not been approved by the FDA or any other regulatory agency. It is being studied for its safety, tolerability, and immunogenicity in healthy volunteers.
INO-4800 has been studied in two completed Phase 1 clinical trials. The first trial, NCT04336410, enrolled 120 healthy volunteers in the United States. The second trial, NCT04447781, enrolled 79 healthy volunteers in South Korea. Both trials evaluated the safety, tolerability, and immunogenicity of INO-4800 for COVID-19.
INO-4800 is a small molecule designed to prevent coronavirus infection. It is being studied for its ability to generate an immune response against the virus. The drug is administered followed by electroporation, a technique that uses electrical pulses to enhance cellular uptake of the drug, as seen in one of its clinical trials.