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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 developed by Inovio Pharmaceuticals, Inc. (ticker INO) that targets the Zika virus. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The product is a monoclonal antibody modality and remains in clinical development.
INO-A002 targets the Zika virus. It is a monoclonal antibody designed against this viral target, which places it in the antiviral target class. The candidate was evaluated in healthy volunteers rather than in patients with an active Zika infection during its completed Phase 1 study.
INO-A002 is developed by Inovio Pharmaceuticals, Inc., which trades under the ticker INO. The company sponsored the Phase 1 study of the candidate. Inovio is the developer associated with this monoclonal antibody program targeting the Zika virus.
INO-A002 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are currently listed for the candidate. It is an investigational product and has not been approved by the FDA for any indication.
INO-A002 has been studied in one completed Phase 1 trial, NCT03831503, titled A Study of INO-A002 in Healthy Dengue Virus-naive Adults. That trial enrolled 30 healthy volunteers in the United States, included both sexes, and used a controlled design without randomization or double blinding.
INO-A002 is not approved. It is an investigational monoclonal antibody that has completed a Phase 1 trial in healthy volunteers. No regulatory approval has been granted for this candidate, and its clinical development remains at the early-stage Phase 1 level.