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 product developed by Inovio Pharmaceuticals for coronavirus infection, including SARS-CoV-2. It was studied in Phase 1 clinical trials as a preventive candidate in healthy adult volunteers. It is not an approved product and remains in clinical development.
INO-4800 was developed for coronavirus infection, specifically SARS-CoV-2, the virus that causes COVID-19. Its clinical program evaluated safety, tolerability, and immunogenicity in healthy volunteers rather than in patients with active disease. The studies are complete, and the candidate is not approved for any use.
INO-4800 is developed by Inovio Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker INO. The company sponsored both Phase 1 trials of the candidate, one conducted in the United States and one in South Korea, in healthy adult volunteers.
INO-4800 has been studied in Phase 1 clinical trials, and both of its trials are now completed. No later-stage trials are listed as active. It is an investigational candidate and is not approved by the FDA or any other regulatory agency for coronavirus infection.
INO-4800 was evaluated in two completed Phase 1 trials. NCT04336410 tested safety, tolerability, and immunogenicity in 120 healthy volunteers in the United States. NCT04447781 tested the same endpoints in 79 healthy volunteers in South Korea. Together the trials enrolled 199 participants, with randomized, double-blind, controlled designs.