Active — Not RecruitingNot Applicable

Medicsen Smartpatch: Safety & Performance (SOUNDD)

Spain30 participantsStarted 2026-01-20

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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., eczem…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Periprocedural

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

Timeframe: Periprocedural

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

Timeframe: 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)

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

Trial details

NCT IDNCT07615959

SponsorMedicsensors S.L

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

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

Timeframe: Periprocedural

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

Timeframe: Periprocedural

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

Timeframe: 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)

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