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

Merck Sharp & Dohme LLC24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

V930BIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

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.

Data from ClinicalTrials.gov

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