Open-Label Study of INO-4212 With or Without INO-9012, Administered IM or ID Followed by Electroporation in Healthy Volunteers

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 remain sexually abstinent, use medically effective contraception (oral contraception, barrier methods, spermicide, etc.) or have a partner who is sterile from enrollment to 3 months following the last injection; OR, sexually active men who are considered sexually fertile must agree to use either a barrier method of contraception during the study, and agree to continue the use for at least 3 months following the last injection, or have a partner who is permanently sterile or unable to become pregnant;
• Normal screening ECG or screening ECG with no clinically significant findings;
• Screening laboratory (Complete blood count (CBC), serum electrolytes, blood urea nitrogen (BUN), creatinine (Cr), glucose, ALT, CPK, urinalysis) grade 0-1 within 30 days prior to administration of study treatment;
• No history of clinically significant immunosuppressive or autoimmune disease.

Exclusion Criteria:

• Administration of an investigational compound either currently or within 30 days of first dose;
• Previous receipt of an investigational product in an interventional trial for the treatment or prevention of Ebola (exceptions: verified receipt of placebo only or participation in an observational study);
• History of or positive serologic test for HIV, hepatitis B surface antigen (HBsAg); or any potentially communicable infectious disease as determined by the Principal Investigator or Medical Monitor;
• Positive serologic test for hepatitis C (exception: successful treatment with confirmation of sustained virologic response);
• Baseline creatinine greater than 1.5 (CKD Stage II or greater);
• Chronic liver disease or cirrhosis;
• Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation;
• Any pre-excitation syndromes, e.g., Wolff-Parkinson-White syndrome;
• Prior major surgery or radiation therapy within 4 weeks of randomization;
• Pregnant, breast feeding, or considering becoming pregnant;
• Less than two acceptable sites exist for intramuscular or intradermal injection and EP between use of the deltoid and lateral quadriceps muscles. A site for injection/EP is not acceptable if there are tattoos, keloids or hypertrophic scars within 2 cm of the injection/EP site.
• Subject has significant acute or chronic medical illness if deemed by the practitioner that electroporation treatment could negatively impact the illness
• Subject has unstable or life-threatening cardiac disease (e.g. unstable angina, class 3 or higher congestive heart failure)
• Subject has an acute or chronic bleeding or clotting disorder that would contraindicate IM injections or use of blood thinners (e.g. anticoagulants or antiplatelet drugs) within 2 weeks;
• Subject has a cardioverter-defibrillator or pacemaker (to prevent a life-threatening arrhythmia) that is located ipsilateral to the intended deltoid injection site (unless deemed acceptable by a Cardiologist);
• Subject has metal implant or implantable medical device within the electroporation area;
• Administration of any vaccine within 4 weeks of first dose;
• Administration of any blood product within 3 months of first dose;
• Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, or low-dose methotrexate). Systemic corticosteroids must be discontinued at least 4 weeks prior to first dose;
• Current or anticipated treatment with TNF-α inhibitors such as infliximab, adalimumab, etanercept;
• Active military service personnel;
• Prisoner or subjects who are compulsorily detained (involuntary incarceration) for treatment of either a physical or psychiatric illness;
• Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints; or
• Any illness or condition that in the opinion of the investigator may affect the safety of the subject or the evaluation of any study endpoint.