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Medicsen Smartpatch: Safety & Performance (SOUNDD)

NCT07615959 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-29

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DEVICE

Medicsen Smartpatch

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.

DEVICE

Subcutaneous (SC) single dose

This intervention consists of administering the drug via standard subcutaneous injection using a pre-filled pen injector

Sponsors & Collaborators

  • SmartBIO Analytics

    collaborator UNKNOWN

  • Hospital Universitario Ramon y Cajal

    collaborator OTHER

  • Avania

    collaborator INDUSTRY

  • Medicsensors S.L

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-01-20
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07615959 on ClinicalTrials.gov