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Medicsen Smartpatch: Safety & Performance (SOUNDD) (SOUNDD)

25. Mai 2026 aktualisiert von: Medicsensors S.L

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

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.

Studienübersicht

Status

Aktiv, nicht rekrutierend

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

30

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Spanien
    • Madrid
      • Madrid, Madrid, Spanien, 28034
        • Hospital Universitario Ramon Y Cajal

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Sonophoresis
In the sonophoresis arm, the drug is administered to the volunteers through the application of ultrasound waves that increase the skin permeability.
Gerät: 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.
Aktiver Komparator: Subcutaneous injection
In the subcutaneous injection arm, the drug is administered to the volunteers through means of subcutaneous injection.
Gerät: Subcutaneous (SC) single dose
This intervention consists of administering the drug via standard subcutaneous injection using a pre-filled pen injector

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Stage 1 - Device-related adverse events (adverse device effects; ADEs)
Zeitfenster: 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.
Periprocedural
Stage 1 - Assessment of local tolerability through questionnaires and visual examination
Zeitfenster: 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.
Periprocedural
Stage 2 - Area under the curve (AUC0-∞ and AUC0-t)
Zeitfenster: 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
Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose
Stage 2 - Peak plasma concentration (Cmax)
Zeitfenster: 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
Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Stage 1 - Peak plasma concentration (Cmax)
Zeitfenster: 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.
Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose
Stage 1 -Area under the curve (AUC0-∞ and AUC0-t)
Zeitfenster: 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.
Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose
Stage 1 - Tmax and t1/2
Zeitfenster: 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.
Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose
Stage 1 - Time at which the device notifies that the full dose has been delivered.
Zeitfenster: Periprocedural
Secondary Outcome Measure of Stage 1.
Periprocedural
Stage 2 - Tmax and t1/2
Zeitfenster: 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.
Prior intervention and 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 60, 70, 80, 90, 120, 180, 240 minutes post-dose
Stage 2 - Incidence and severity of ADEs
Zeitfenster: Periprocedural
Secondary Outcome Measure of Stage 2.
Periprocedural
Stage 2 - Number of participants with treatment-emergent clinically significant abnormalities in laboratory parameters (hematology and biochemistry)
Zeitfenster: 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
Through study completion
Stage 2 - Number of participants with treatment-emergent clinically significant abnormalities in vital signs.
Zeitfenster: 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
Through study completion
Stage 2 - Number of participants with changes in electrocardiogram from baseline
Zeitfenster: 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.
Through study completion
Stage 2 - Assessment of local tolerability through questionnaires and visual examination
Zeitfenster: 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.
Periprocedural
Stage 2 - Time at which the device notifies that the full dose has been delivered.
Zeitfenster: Periprocedural
Secondary Outcome Measure of Stage 2
Periprocedural
Stage 2 - Usability endpoints (for healthcare professionals)
Zeitfenster: 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.
Immediately after the intervention
Stage 2 - Usability endpoints (for patients)
Zeitfenster: 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.
Immediately after the intervention

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Medicsensors S.L

Mitarbeiter

Hospital Universitario Ramon y Cajal
Avania
SmartBIO Analytics

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

20. Januar 2026

Primärer Abschluss (Geschätzt)

1. November 2026

Studienabschluss (Geschätzt)

1. November 2026

Studienanmeldedaten

Zuerst eingereicht

30. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Mai 2026

Zuerst gepostet (Tatsächlich)

29. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

29. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Mai 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MSP-001

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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