Phase I Safety and Pharmacokinetic Study of VGX-1027 in Healthy Subjects

Study Overview
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Brief Summary
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To assess the safety and tolerability of a single dose of VGX-1027 in the range of 1-800mg.

Detailed Description
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This study will evaluate: The safety and tolerability of a single dose of VGX-1027 as determined by: adverse event reporting, clinical laboratory results, vital signs, physical examinations, and electrocardiograms (ECGs). The pharmacokinetic (PK) profile of VGX-1027 maximum concentration (Cmax)

Official Title
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A Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety and Pharmacokinetics of VGX-1027 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: VGX-1027


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must give written informed consent. Healthy 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 of 18-30kg/m^2 inclusive Males or females ages 18-60, inclusive. Women who are not of childbearing potential may enroll. Women must have a negative pregnancy test within 72 hours prior to start of study drug administration or be surgically sterile. 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 the study and for three months following dosing Any significant acute or chronic mental illness Current or recent 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 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 determinations 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 drug within 4 weeks prior to enrollment or greater that 4 weeks for investigational drugs that may have a longer half-life Use of any prescription drugs or 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 3 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 must not be enrolled into this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1mg dose group | Drug: VGX-1027<br>* Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.<br>|
| Experimental: 2<br>10mg dose group | Drug: VGX-1027<br>* Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.<br>|
| Experimental: 3<br>100mg dose group | Drug: VGX-1027<br>* Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.<br>|
| Experimental: 4<br>200mg dose group | Drug: VGX-1027<br>* Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.<br>|
| Experimental: 5<br>400mg dose group | Drug: VGX-1027<br>* Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.<br>|
| Experimental: 6<br>800mg dose group | Drug: VGX-1027<br>* Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as determined by vital signs, physical examinations, ECGs, clinical laboratory evaluations, and AE reporting. |  | Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | Day 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy volunteers