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NCT Number: NCT07615959

Medicsen Smartpatch: Safety & Performance (SOUNDD)

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Ramon y Cajal

Madrid, 28034, Spain

About this study

The clinical investigation will be conducted in two stages:

Stage 1: A first-in-human pilot study to evaluate the safety, tolerability, and exploratory performance of the Medicsen Smartpatch for drug delivery in healthy volunteers: a single-center, open-label study.

Stage 2: A confirmatory study to evaluate the performance of the Medicsen Smartpatch by comparing sonophoresis with subcutaneous drug delivery: a randomized, single-dose, open-label, two-way crossover study in healthy volunteers.

Study subjects will be monitored for device-attributable adverse effects during the scheduled examinations and at any examinations resulting from study subjects' self-reported concerns. A licensed physician will review any unanticipated adverse events associated with the protocol.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects must provide signed informed consent prior to participation in any study related procedures
  • Healthy Caucasian volunteers, any sex, aged between 18 to 55 years
  • Body Mass Index (BMI) between 18.5 and 30.0 kg/m2
  • Ability and agreement to comply with the study requirements
  • Medical history and physical examination within normal limits.
  • No clinically relevant abnormalities in hematology, biochemistry, virology, or urine tests.
  • Participants who engage in sexual activity which could result in pregnancy for themselves or their partner(s) must agree to use highly effective methods of contraception during the clinical investigation.

Exclusion criteria

  • Case history of hypersensitivity to medicinal products or any other allergic process that could interfere with study according to the investigator's judgement.
  • Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplasic, hepatopathy, dermatology, gastrointestinal distress, hypertension, or infectious acute processes that could interfere with study according to the investigator's judgement.
  • Previous chronic processes or with rebound characteristics that could interfere with study according to the investigator's judgement.
  • Administration of topic or systemic medication including medicinal plants within 14 days before the intervention.
  • Presence of skin disorders or lesions at the intended application site (e.g., eczema, psoriasis, infections, open wounds), which may interfere with drug absorption or increase risk of adverse effects.
  • Implanted electronic medical devices, such as pacemakers or neurostimulators, due to potential interference with ultrasonic energy.
  • Pregnant or breastfeeding women, due to lack of safety data for either the drug or the ultrasound application in this population.
  • Severe cognitive or motor impairment, where safe operation of the patch cannot be ensured, unless under continuous caregiver supervision.

Treatment and study plan

Medicsen Smartpatch

Device

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.

Subcutaneous (SC) single dose

Device

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

Primary outcomes

  1. Stage 1 - Device-related adverse events (adverse device effects; ADEs)

    Time frame: Periprocedural

    Primary Outcome Measure of Stage 1.

    Incidence and severity of ADEs is assesed, with special focus on those occurred at the site of administration and those leading to treatment interruption.

  2. Stage 1 - Assessment of local tolerability through questionnaires and visual examination

    Time frame: Periprocedural

    Primary Outcome Measure of Stage 1.

    Subject-reported sensations (pain/burning, itching/stinging, discomfort) during and after administration are assesed through questionnaires.

    Dermatologist-evaluated skin signs (erythema, edema, vesicles, crusts/exudate, scaling/lichenification, hematomas/bleeding, tenderness) are assesed through visual examination.

  3. Stage 2 - Area under the curve (AUC0-∞ and AUC0-t)

    Time frame: Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose

    Primary Outcome Measure of Stage 2

  4. Stage 2 - Peak plasma concentration (Cmax)

    Time frame: Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose

    Primary Outcome Measure of Stage 2

Secondary outcomes

  1. Stage 1 - Peak plasma concentration (Cmax)

    Time frame: Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose

    Secondary Outcome Measure of Stage 1.

  2. Stage 1 -Area under the curve (AUC0-∞ and AUC0-t)

    Time frame: Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose

    Secondary Outcome Measure of Stage 1.

  3. Stage 1 - Tmax and t1/2

    Time frame: Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose

    Secondary Outcome Measure of Stage 1.

  4. Stage 1 - Time at which the device notifies that the full dose has been delivered.

    Time frame: Periprocedural

    Secondary Outcome Measure of Stage 1.

  5. Stage 2 - Tmax and t1/2

    Time frame: Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose

    Secondary Outcome Measure of Stage 2.

  6. Stage 2 - Incidence and severity of ADEs

    Time frame: Periprocedural

    Secondary Outcome Measure of Stage 2.

  7. Stage 2 - Number of participants with treatment-emergent clinically significant abnormalities in laboratory parameters (hematology and biochemistry)

    Time frame: Through study completion

    Secondary Outcome Measure of Stage 2.

    Number of participants with laboratory values outside the normal reference range that are considered clinically significant compared to baseline. This includes hematology (hemoglobin, hematocrit, Red blood cell, MCV, MCH, MCHC, White blood cell with differential, and platelets) and biochemistry (urea, creatinine, glucose, AST (SGOT), ALT (SGPT), GGT, ALP, and total bilirubin).

    Unit of measure: Participants

  8. Stage 2 - Number of participants with treatment-emergent clinically significant abnormalities in vital signs.

    Time frame: Through study completion

    Secondary Outcome Measure of Stage 2.

    Number of participants with vital sign values outside the normal reference range that are considered clinically significant compared to baseline. This includes Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP), Heart Rate (HR), Respiratory Rate (RR), and Temperature (T) measured before and after the procedure.

    Unit of measure: Participants

  9. Stage 2 - Number of participants with changes in electrocardiogram from baseline

    Time frame: Through study completion

    Secondary Outcome Measure of Stage 2.

    A standard 12-lead ECG is performed with an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QTc intervals before and after the procedure to determine changes from baseline values.

  10. Stage 2 - Assessment of local tolerability through questionnaires and visual examination

    Time frame: Periprocedural

    Secondary Outcome Measure of Stage 2.

    Subject-reported sensations (pain/burning, itching/stinging, discomfort) during and after administration of both interventions are assesed through questionnaires.

    Dermatologist- evaluated skin signs (erythema, edema, vesicles, crusts/exudate, scaling/lichenification, hematomas/bleeding, tenderness) after Medicsen Smartpatch intervention are assesed through visual examination.

  11. Stage 2 - Time at which the device notifies that the full dose has been delivered.

    Time frame: Periprocedural

    Secondary Outcome Measure of Stage 2

  12. Stage 2 - Usability endpoints (for healthcare professionals)

    Time frame: Immediately after the intervention

    Secondary Outcome Measure of Stage 2.

    Rate of first-attempt success, time to complete setup, clarity of instructions, and user-reported ease-of-use scores for healthcare professionals are assesed through the Healthcare Proffesionals' Usability Questionnaire, in which a score from 1 to 5 is given to each of the measurements, and where a higher score means a worse outcome.

  13. Stage 2 - Usability endpoints (for patients)

    Time frame: Immediately after the intervention

    Secondary Outcome Measure of Stage 2.

    Comfort and willingness to reuse the device are assesed through the Patient's Usability Questionnaire, in which a score from 1 to 5 is given to each of the measures, and where a higher score means a worse outcome.

Sponsors and collaborators

Lead sponsor

Medicsensors S.L

Industry

Collaborators

  • Avania
  • Hospital Universitario Ramon y Cajal
  • SmartBIO Analytics

Registry information

Official study title

Clinical Investigation to Evaluate the Safety, Tolerability and Performance of the Medicsen Smartpatch, a Non-Invasive Ultrasound-Based Drug Delivery Medical Device (SOUNDD Study)

Acronym: SOUNDD

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 29, 2026
Registry last updated
May 29, 2026

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.

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