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

NCT00627120 | Completed Phase 1

• 1 other identifier: CAT001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Safety as determined by vital signs, physical examinations, ECGs, clinical laboratory evaluations, and AE reporting.

  Day 8

Secondary Outcomes (1)

• Pharmacokinetics

  Day 4

Study Arms (6)

1

EXPERIMENTAL

1mg dose group

Drug: VGX-1027

2

EXPERIMENTAL

10mg dose group

Drug: VGX-1027

3

EXPERIMENTAL

100mg dose group

Drug: VGX-1027

4

EXPERIMENTAL

200mg dose group

Drug: VGX-1027

5

EXPERIMENTAL

400mg dose group

Drug: VGX-1027

6

EXPERIMENTAL

800mg dose group

Drug: VGX-1027

Interventions

VGX-1027 DRUG

Subject will be given a single dose of VGX-1027 ranging from 1-800mg and monitored for safety and pharmacokinetics for 8 days.

1; 2; 3; 4; 5; 6

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VGX Pharmaceuticals, LLC: lead
• GeneOne Life Science, Inc.: collaborator

Study Sites (1)

SNBL Clinical Pharmacology Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Interventions

3-phenyl-4,5-dihydro-5-isoxazole acetic acid

Study Officials

• Stephan A Bart, MD

  SNBL Clinical Pharmacology Center, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 17, 2008
• First Posted: February 29, 2008
• Study Start: February 1, 2008
• Primary Completion: September 1, 2008
• Last Updated: January 9, 2009

Record last verified: 2009-01

Locations

US (1)