Healthy
Conditions
Keywords
healthy volunteers
Brief summary
To assess the safety and tolerability of a single dose of VGX-1027 in the range of 1-800mg.
Detailed description
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)
Interventions
DRUGVGX-1027
Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.
Sponsors
GeneOne Life Science, Inc.
VGX Pharmaceuticals, LLC
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety as determined by vital signs, physical examinations, ECGs, clinical laboratory evaluations, and AE reporting. | Day 8 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | Day 4 |
Countries
United States
Outcome results
None listed