A Study to Test the Tolerability of an Investigational Electroporation Device in Healthy Adults (V930-001)

This study has been completed.
Sponsor:
Collaborators:
University of California, San Diego
Inovio Pharmaceuticals
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00721461
First received: July 22, 2008
Last updated: May 21, 2014
Last verified: May 2014

July 22, 2008
May 21, 2014
May 2005
October 2005   (final data collection date for primary outcome measure)
Assess the tolerability of the MedPulser DDS device. [ Time Frame: Severity of pain will be measured at time of treatment and 1, 5, 10, and 20 minutes and 24 hours after electrostimulation. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00721461 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study to Test the Tolerability of an Investigational Electroporation Device in Healthy Adults (V930-001)
Probe Study of the Tolerability of an Investigational Electroporation Device, MedPulser (Trademark) DNA Delivery System (DDS) in Healthy Adults 18 to 35 Years of Age

A study to evaluate the tolerability of electrostimulation applications with an investigational device known as the MedPulser DDS.

Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Healthy
Biological: V930
Intramuscular injection of phosphate buffered saline solution will be given and within 2 - 5 minutes will be followed by an electrostimulation pulse with the MedPulser DDS in the deltoid muscle of the right arm. 15 days later, the same procedure will take place using the left arm.
Experimental: 1
V930
Intervention: Biological: V930
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
October 2005
October 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be between the ages of 18 and 35
  • Woman who are able to become pregnant must use an acceptable form of birth control

Exclusion Criteria:

  • You are breast feeding
  • You have taken any type of pain reliever within 12 hours of electrostimulation
  • You have participated in another clinical study within 4 weeks of starting this study or plan to participate in another clinical study while participating in this study
  • You have muscle atrophy, weakness or neuromuscular disorder
Both
18 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00721461
V930-001, 2008_537
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
  • University of California, San Diego
  • Inovio Pharmaceuticals
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP