Medicsen Smartpatch: Safety & Performance (SOUNDD)

NCT07615959 | Active Not Recruiting DMC

• 1 other identifier: MSP-001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

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

  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

  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)

  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)

  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

Secondary Outcomes (13)

• Stage 1 - Peak plasma concentration (Cmax)

  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)

  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

  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.

  Periprocedural

• Stage 2 - Tmax and t1/2

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

Study Arms (2)

Sonophoresis

EXPERIMENTAL

In the sonophoresis arm, the drug is administered to the volunteers through the application of ultrasound waves that increase the skin permeability.

Device: Medicsen Smartpatch

Subcutaneous injection

ACTIVE COMPARATOR

In the subcutaneous injection arm, the drug is administered to the volunteers through means of subcutaneous injection.

Device: Subcutaneous (SC) single dose

Interventions

Subcutaneous (SC) single dose DEVICE

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

Subcutaneous injection

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.

Sonophoresis

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medicsensors S.L: lead
• SmartBIO Analytics: collaborator
• Avania: collaborator
• Hospital Universitario Ramon y Cajal: collaborator

Study Sites (1)

Hospital Universitario Ramon y Cajal

Madrid, Madrid, 28034, Spain

Location

Related Publications (19)

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• McLenon J, Rogers MAM. The fear of needles: A systematic review and meta-analysis. J Adv Nurs. 2019 Jan;75(1):30-42. doi: 10.1111/jan.13818. Epub 2018 Sep 11.

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• Williams AR. Phonophoresis: an in vivo evaluation using three topical anaesthetic preparations. Ultrasonics. 1990 May;28(3):137-41. doi: 10.1016/0041-624x(90)90075-y.

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• Levy D, Kost J, Meshulam Y, Langer R. Effect of ultrasound on transdermal drug delivery to rats and guinea pigs. J Clin Invest. 1989 Jun;83(6):2074-8. doi: 10.1172/JCI114119.

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  PMID: 23899825 BACKGROUND

• Polat BE, Hart D, Langer R, Blankschtein D. Ultrasound-mediated transdermal drug delivery: mechanisms, scope, and emerging trends. J Control Release. 2011 Jun 30;152(3):330-48. doi: 10.1016/j.jconrel.2011.01.006. Epub 2011 Jan 14.

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  PMID: 10839713 BACKGROUND

MeSH Terms

Interventions

Injections, Subcutaneous

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 29, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)