Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2026-03-09 @ 12:05 PM
Study NCT ID:
NCT00627120
Status:
COMPLETED
Last Update Posted:
2009-01-09
First Post:
2008-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Safety and Pharmacokinetic Study of VGX-1027 in Healthy Subjects
Sponsor:
VGX Pharmaceuticals, LLC
Organization:
Study Overview
Official Title:
A Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety and Pharmacokinetics of VGX-1027 in Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2009-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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)
* 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)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: