NCT00627120

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: VGX Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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)

Conditions

• Healthy

Interventions

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

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-09-01
• First posted: 2008-02-29
• Last updated: 2009-01-09

Locations

1 site across 1 country: United States