Medicsen Smartpatch: Safety & Performance (SOUNDD)

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.

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.

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.