At a glance
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Clinical Investigation to Evaluate the Safety, Tolerability and Performance of the Medicsen Smartpatch, a Non-Invasive Ultrasound-Based Drug Delivery Medical Device (SOUNDD Study)
In Brief
A clinical study evaluating Medicsen Smartpatch and Subcutaneous (SC) single dose for Healthy. Active but no longer recruiting, targeting 30 participants across 1 site.
Detailed Summary
The goal of this clinical trial is to understand the efficacy of Medicsen's Smartpatch to deliver drugs through the skin in healthy volunteers. The main questions it aims to answer are: * Is the administration with Medicsen Smartpatch safe for the patient? * Can Medicsen's Smartpatch be used to effectively administer drugs to patients? Researchers will compare administration with Medicsen's Smartpatch with the subcutaneous administration of the drug to see if the efficacy and safety are comparable Participants will be asked to fill a tolerability survey after receiving each of the two interventions: Subcutaneous administration and Medicse's Smartpatch. Blood samples will be taken at different timepoints to asses for efficacy of each treatment.
Study Details
Timeline
Interventions
This intervention consists of administering the drug using the Medicsen Smartpatch, a non-invasive, needle-free drug delivery device that utilizes sonophoresis technology to enhance absorption through the skin.
This intervention consists of administering the drug via standard subcutaneous injection using a pre-filled pen injector