Healthy
Conditions
Keywords
Assess, Tolerability, MedPulser DDS device
Brief summary
A study to evaluate the tolerability of electrostimulation applications with an investigational device known as the MedPulser DDS.
Interventions
BIOLOGICALV930
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.
Sponsors
University of California, San Diego
Inovio Pharmaceuticals
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assess the tolerability of the MedPulser DDS device. | Severity of pain will be measured at time of treatment and 1, 5, 10, and 20 minutes and 24 hours after electrostimulation. |
Outcome results
None listed