Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
INO-A002 · 1 trial · 1 indication
Safety will be assessed by monitoring the frequency and severity of adverse events utilizing the "Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials" with labs assessed as per site normal values.
Pain will be assessed by administration (i.e., injection) site reactions (frequency and severity) and visual analogue scale (VAS) scores.
The maximum serum concentration (Cmax) assessment will be performed by the analysis of dMAb-ZK190 levels at baseline; days 1, 3, 7 and at weeks 2, 3, 4, 5, 6, 8, 12, 16, 24 and 52. Serum concentration in micrograms/mL will be used as the measurement scale.
The minimum serum concentration (Cmin) assessment will be performed by the analysis of dMAb-ZK190 levels at baseline; days 1, 3, 7 and at weeks 2, 3, 4, 5, 6, 8, 12, 16, 24 and 52. Serum concentration in micrograms/mL will be used as the measurement scale.
The Area Under the Curve (AUC0-t) will be performed by the analysis of dMAb-ZK190 levels at baseline; days 1, 3, 7 and at weeks 2, 3, 4, 5, 6, 8, 12, 16, 24 and 52. The Area Under the Curve (AUC0-t) against time will be calculated using the trapezoidal method.
| Arm | Type | Description |
|---|---|---|
| Cohort A - 0.5mg | EXPERIMENTAL | Participants (n=6 per cohort) will be administered 1 injection (Day 0) of INO-A002 at 0.5 mg DNA/dose. Inoculation will be administered as 0.5 ml IM injection followed by electroporation with the CELLECTRA® 2000 device. |
| Cohort B - 1mg | EXPERIMENTAL | Participants (n=6 per cohort) will be administered 1 injection (Day 0) of INO-A002 at 1 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device. |
| Cohort C - 2mg | EXPERIMENTAL | Participants (n=6 per cohort) will be administered 2 injections (Day 0 and Day 3) of INO-A002 at 2 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device. |
| Cohort D - 4mg | EXPERIMENTAL | Participants (n=6 per cohort) will be administered 2 injections (Day 0 and Day 3) of INO-A002 at 4 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device. |
| Cohort E - 4mg Side Port | EXPERIMENTAL | Participants (n=6 per cohort) will be administered 2 injections (Day 0 and Day 3) of INO-A002 at 4 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device with Side Port needle. |
| Name | Type | Description |
|---|---|---|
| INO-A002 | BIOLOGICAL | Participants will receive one or two 1 ml IM injections (in different arms) into the deltoid region at day 0 (all groups), and in addition on day 3 (in the 2 mg and 4 mg cohorts). |
| CELLECTRA® 2000 | DEVICE | Inoculation will be followed by electroporation with the CELLECTRA® 2000 device. |
| Dengue Fever Antibodies (IgG) | DEVICE | To determine if the subject is Dengue seronegative at baseline |
1. Age 18-60 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. Body mass index (BMI) between 20 and 30, inclusive 5. Screening laboratory must be within normal limits or have only Grade 0-1 f...
INO-A002 is an investigational monoclonal antibody being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial in healthy dengue virus-naive adults in the United States. The drug is not approved and is still in clinical development.
INO-A002 is being developed by Inovio Pharmaceuticals, Inc., a company traded on the stock exchange under the ticker symbol INO. The company is conducting a Phase 1 clinical trial of this investigational monoclonal antibody in healthy volunteers.
INO-A002 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied in a completed Phase 1 trial in healthy volunteers, and it remains in the clinical development stage.
INO-A002 is associated with one clinical trial, identified as NCT03831503, titled "A Study of INO-A002 in Healthy Dengue Virus-naive Adults." This Phase 1 trial was conducted in the United States and enrolled 30 participants, all healthy volunteers aged 18 years and older.
Yes, INO-A002 is a monoclonal antibody. It is being developed by Inovio Pharmaceuticals and is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers, and its development is focused on evaluating its safety and other characteristics in this population.