Multiple-Dose Study of VGX-1027 in Healthy Subjects

NCT00760396 | Completed Phase 1

• 1 other identifier: CAT002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the safety profile, tolerability and pharmacokinetics following multiple oral doses of 40mg to 200mg VGX 1027 in healthy subjects administered for 5 days.

Conditions

Healthy

Keywords

healthy volunteers

Outcome Measures

Primary Outcomes (1)

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

  Day 8

Secondary Outcomes (1)

• Pharmacokinetics

  Day 8

Study Arms (4)

Group 1

EXPERIMENTAL

40mg QD dose group

Drug: VGX-1027

Group 2

EXPERIMENTAL

100mg QD dose group

Drug: VGX-1027

Group 3

EXPERIMENTAL

200mg QD dose group

Drug: VGX-1027

Group 4

EXPERIMENTAL

200mg BID dose group

Drug: VGX-1027

Interventions

VGX-1027 DRUG

Subjects will

Group 1; Group 2; Group 3; Group 4

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.
• 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.

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 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.

Sponsors & Collaborators

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

Study Sites (1)

SNBL Clinical Pharmacology Center, Inc.

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: September 25, 2008
• First Posted: September 26, 2008
• Study Start: September 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: April 1, 2009
• Last Updated: April 7, 2009

Record last verified: 2009-04

Locations

US (1)