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

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

V930

Biological

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

Inovio Pharmaceuticals
University of California, San Diego

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2005
Study completion: 2005
First posted: Jul 24, 2008
Registry last updated: Aug 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed