Multiple-Dose Study of VGX-1027 in Healthy Subjects

This study will evaluate:

• The safety and tolerability of multiple oral doses of VGX 1027 in the range of 40 to 400mg.
• The pharmacokinetics of VGX 1027 in healthy subjects following the first oral dose (Day 1) and at steady state (Day 5).

Inclusion criteria

• Must give written informed consent.
• Healty subjects as determined by no clinically significant deviation from normal as judged by the investigator in medical history, physical examination, ECGs and clinical laboratory evaluations.
• Body Mass Index (BMI) of 18 to 30kg/m2 ±0.5kg/m2 inclusive.

Exclusion criteria

• Women who are of childbearing potential.
• Women who are pregnant or breastfeeding.
• Women with a positive pregnancy test on enrollment or prior to study drug administration.
• Male subjects who are unwilling to agree to practice barrier contraception during study participation and 3 months following dosing.
• Any significant acute or chronic medical illness
• Current or recent (within 3 months) gastrointestinal disease that may impact the absorption of the drug.
• Any major surgery within 4 weeks of enrollment.
• Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of enrollment.
• Blood transfusion within 4 weeks of enrollment.
• Inability to tolerate oral medication.
• Inability to be venipunctured and/or tolerate venous access.
• Recent (within 6 months) drug or alcohol abuse.
• History of bleeding disorder.
• History of head trauma or seizures.
• Any other sound medical, psychiatric and/or social reason as determined by the Investigator.
• Evidence of organ dysfunction or any clinically significant deviation from normal in vital signs, physical examination, ECG, or clinical laboratory determination.
• Positive urine screen for drugs of abuse
• Positive blood screen for hepatitis C antibody, hepatitis B surface antigen, HIV 1/2 antibody
• History of any significant drug allergy
• Exposure to any investigational druge within 4 weeks prior to enrollment or greater than 4 weeks for investigational drugs that may have a longer half life.
• Use of any prescription drugs, over the counter acid controllers within 4 weeks prior to enrollment.
• Use of any other drugs, including over the counter vitamins, medications and/or herbal preparations within 2 weeks prior to enrollment
• Use of oral, injectable or implantable hormonal contraceptive agents within three months prior to enrollment
• Use of alcohol containing beverages within 1 week prior to enrollment
• Use of grapefruit containing products within 1 week prior to enrollment
• Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness