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VGX-1027

Phase 1

Undisclosed | Small molecule | Other |Inovio Pharmaceuticals, Inc.|Trials Updated: Apr 7, 2009

VGX-1027 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Feb 2008

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment88

FDA Designations

No designations recorded

VGX-1027 clinical trials

VGX-1027 · 2 trials · 1 indication

Phase 1 2
NCT00760396Multiple-Dose Study of VGX-1027 in Healthy SubjectsHealthy
COMPLETED40 Analytics
NCT00627120Phase I Safety and Pharmacokinetic Study of VGX-1027 in Healthy SubjectsHealthy
COMPLETED48 Analytics
PHASE1COMPLETED
Multiple-Dose Study of VGX-1027 in Healthy Subjects
HealthyUnlock trial analytics
PHASE1COMPLETED
Phase I Safety and Pharmacokinetic Study of VGX-1027 in Healthy Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety as determined by vital signs, ECGs, clinical laboratory evaluations and AE reporting.
Day 8
Safety as determined by vital signs, physical examinations, ECGs, clinical laboratory evaluations, and AE reporting.
Day 8

Secondary Endpoints

Pharmacokinetics
Day 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Group 1EXPERIMENTAL40mg QD dose group
Group 2EXPERIMENTAL100mg QD dose group
Group 3EXPERIMENTAL200mg QD dose group
Group 4EXPERIMENTAL200mg BID dose group
1EXPERIMENTAL1mg dose group
2EXPERIMENTAL10mg dose group
3EXPERIMENTAL100mg dose group
4EXPERIMENTAL200mg dose group
5EXPERIMENTAL400mg dose group
6EXPERIMENTAL800mg dose group

Interventions

NameTypeDescription
VGX-1027DRUGSubjects will
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 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....

Countries:United States
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Frequently asked questions about VGX-1027

What is VGX-1027?

VGX-1027 is an investigational small molecule drug developed by Inovio Pharmaceuticals, Inc. It has been studied in Phase 1 clinical trials in healthy adult volunteers in the United States. Its therapeutic indications have not been publicly disclosed, and it remains in early clinical development rather than approved for any use.

Who makes VGX-1027?

VGX-1027 is being developed by Inovio Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker INO. Inovio is the sponsor of the clinical program for this small molecule asset.

What phase is VGX-1027 in?

VGX-1027 is in Phase 1 development. Both of its recorded clinical trials were Phase 1 studies, and both have been completed. There are currently no active trials of VGX-1027, so the program is not presently enrolling or dosing patients.

What clinical trials has VGX-1027 been studied in?

VGX-1027 has been evaluated in two completed Phase 1 trials. NCT00627120 was a Phase 1 safety and pharmacokinetic study in 48 healthy subjects. NCT00760396 was a multiple-dose study in 40 healthy subjects. Both were conducted in the United States and together enrolled 88 participants.

Were the VGX-1027 trials randomized and blinded?

Yes. The VGX-1027 Phase 1 program used a randomized, double-blind, controlled design. Both completed studies enrolled healthy adult volunteers aged 18 years and older, with enrollment of 48 subjects in NCT00627120 and 40 subjects in NCT00760396.

Is VGX-1027 approved by the FDA?

VGX-1027 is not an approved medicine. It is an investigational small molecule that has completed Phase 1 testing in healthy volunteers, and no later-stage trials or regulatory approvals have been recorded for it.