Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02464670 | Open-Label Study of INO-4212 With or Without INO-9012, Administered IM or ID Followed by Electroporation in Healthy Volunteers | PHASE1 | COMPLETED | 240 | — | — | May 1, 2015 | May 24, 2018 | Jun 28, 2019 | 3 | United States |
Composite of multiple measures consist of: * Frequency and severity of all adverse events * Local pain immediately and at 5 and 10 minutes after Study Treatment/EP using a visual analog scale from 0 to 10, with 0 representing "No Pain" and 10 representing "Worst Pain" * Frequency and severity of local and systemic events for at least 7 days after Study Treatment/EP * Frequency and severity of laboratory abnormalities * Changes in vital signs (blood pressure, heart rate, respiratory rate, temperature)
| Arm | Type | Description |
|---|---|---|
| Group 1 | EXPERIMENTAL | INO-4201 IM + EP, 2 mg, 3 doses |
| Group 2 | EXPERIMENTAL | INO-4202 IM + EP, 2 mg, 3 doses |
| Group 3 | EXPERIMENTAL | INO-4201 ID + EP 0.2A, 2 mg, 3 doses |
| Group 4 | EXPERIMENTAL | INO-4212 IM + EP, 4 mg, 3 doses |
| Group 5 | EXPERIMENTAL | INO-4212 + INO-9012 IM + EP, 4+1 mg, 3 doses |
| Group 6 | EXPERIMENTAL | INO-4201 ID + EP 0.2A, 1 mg, 3 doses |
| Group 7 | EXPERIMENTAL | INO-4201 ID + EP 0.2A, 2 mg, 2 doses |
| Group 8 | EXPERIMENTAL | INO-4201 ID + EP 0.2A, 1 mg, 2 doses |
| Group 9 | EXPERIMENTAL | INO-4201 + INO-9012 ID + EP 0.2A, 1.6 + 0.4 mg, 3 doses |
| Group 10 | EXPERIMENTAL | INO-4201 + INO-9012 ID + EP 0.2A, 1.6 + 0.4 mg, 2 doses |
| Group 11 | EXPERIMENTAL | INO-4201 + INO-9012 ID + EP 0.2A, 0.8 + 0.2 mg, 3 doses |
| Part II: Group 3A | EXPERIMENTAL | INO-4201 ID + EP 0.2A, 2 mg, 3 doses |
| Part II: Group 3B | EXPERIMENTAL | INO-4201 ID + EP 0.1A, 2 mg, 3 doses |
| Name | Type | Description |
|---|---|---|
| INO-4201 | BIOLOGICAL | INO-4201 delivered IM followed by Electroporation |
| INO-4202 | BIOLOGICAL | INO-4202 delivered IM followed by Electroporation |
| INO-4212 | BIOLOGICAL | INO-4212 delivered IM followed by Electroporation |
| INO-4212 + INO-9012 | BIOLOGICAL | INO-4212 + INO-9012 delivered IM followed by Electroporation |
| INO-4201 + INO-9012 | BIOLOGICAL | INO-4201 + INO-9012 delivered ID followed by Electroporation |
Inclusion Criteria: * Age 18-50 years; * Able to provide consent to participate and having signed an Informed Consent Form (ICF); * Able and willing to comply with all study procedures; * Women of child-bearing potential who are in a relationship that could result in pregnancy agree to either remai...