Medicsen Smartpatch: Safety & Performance (SOUNDD) (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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Madrid
-
Madrid、Madrid、スペイン、28034
- Hospital Universitario Ramon y Cajal
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Sonophoresis
In the sonophoresis arm, the drug is administered to the volunteers through the application of ultrasound waves that increase the skin permeability.
|
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.
|
|
アクティブコンパレータ：Subcutaneous injection
In the subcutaneous injection arm, the drug is administered to the volunteers through means of subcutaneous injection.
|
This intervention consists of administering the drug via standard subcutaneous injection using a pre-filled pen injector
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Stage 1 - Device-related adverse events (adverse device effects; ADEs)
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Stage 1 - Peak plasma concentration (Cmax)
時間枠：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)
時間枠：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
時間枠：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.
時間枠：Periprocedural
|
Secondary Outcome Measure of Stage 1.
|
Periprocedural
|
|
Stage 2 - Tmax and t1/2
時間枠：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
時間枠：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)
時間枠：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.
時間枠：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
時間枠：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
時間枠：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.
時間枠：Periprocedural
|
Secondary Outcome Measure of Stage 2
|
Periprocedural
|
|
Stage 2 - Usability endpoints (for healthcare professionals)
時間枠：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)
時間枠：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
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
- Mitragotri S, Blankschtein D, Langer R. Ultrasound-mediated transdermal protein delivery. Science. 1995 Aug 11;269(5225):850-3. doi: 10.1126/science.7638603.
- Mannocci A, De Carli G, Di Bari V, Saulle R, Unim B, Nicolotti N, Carbonari L, Puro V, La Torre G. How Much do Needlestick Injuries Cost? A Systematic Review of the Economic Evaluations of Needlestick and Sharps Injuries Among Healthcare Personnel. Infect Control Hosp Epidemiol. 2016 Jun;37(6):635-46. doi: 10.1017/ice.2016.48. Epub 2016 Mar 29.
- Elder A, Paterson C. Sharps injuries in UK health care: a review of injury rates, viral transmission and potential efficacy of safety devices. Occup Med (Lond). 2006 Dec;56(8):566-74. doi: 10.1093/occmed/kql122. Epub 2006 Oct 25.
- Aronson R. The role of comfort and discomfort in insulin therapy. Diabetes Technol Ther. 2012 Aug;14(8):741-7. doi: 10.1089/dia.2012.0038. Epub 2012 Apr 26.
- Wagner J, Malchoff C, Abbott G. Invasiveness as a barrier to self-monitoring of blood glucose in diabetes. Diabetes Technol Ther. 2005 Aug;7(4):612-9. doi: 10.1089/dia.2005.7.612.
- Jenkins K. II. Needle phobia: a psychological perspective. Br J Anaesth. 2014 Jul;113(1):4-6. doi: 10.1093/bja/aeu013. Epub 2014 Feb 25. No abstract available.
- Schoellhammer CM, Polat BE, Mendenhall J, Maa R, Jones B, Hart DP, Langer R, Blankschtein D. Rapid skin permeabilization by the simultaneous application of dual-frequency, high-intensity ultrasound. J Control Release. 2012 Oct 28;163(2):154-60. doi: 10.1016/j.jconrel.2012.08.019. Epub 2012 Aug 23.
- Barati AH, Mokhtari-Dizaji M, Mozdarani H, Bathaie Z, Hassan ZM. Effect of exposure parameters on cavitation induced by low-level dual-frequency ultrasound. Ultrason Sonochem. 2007 Sep;14(6):783-9. doi: 10.1016/j.ultsonch.2006.12.016. Epub 2007 Jan 23.
- Tezel A, Sens A, Mitragotri S. Investigations of the role of cavitation in low-frequency sonophoresis using acoustic spectroscopy. J Pharm Sci. 2002 Feb;91(2):444-53. doi: 10.1002/jps.10024.
- Tachibana K. Transdermal delivery of insulin to alloxan-diabetic rabbits by ultrasound exposure. Pharm Res. 1992 Jul;9(7):952-4. doi: 10.1023/a:1015869420159. No abstract available.
- Tachibana K, Tachibana S. Transdermal delivery of insulin by ultrasonic vibration. J Pharm Pharmacol. 1991 Apr;43(4):270-1. doi: 10.1111/j.2042-7158.1991.tb06681.x.
- 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.
- 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.
- Bommannan D, Okuyama H, Stauffer P, Guy RH. Sonophoresis. I. The use of high-frequency ultrasound to enhance transdermal drug delivery. Pharm Res. 1992 Apr;9(4):559-64. doi: 10.1023/a:1015808917491.
- Mitragotri S, Edwards DA, Blankschtein D, Langer R. A mechanistic study of ultrasonically-enhanced transdermal drug delivery. J Pharm Sci. 1995 Jun;84(6):697-706. doi: 10.1002/jps.2600840607.
- Park D, Park H, Seo J, Lee S. Sonophoresis in transdermal drug deliverys. Ultrasonics. 2014 Jan;54(1):56-65. doi: 10.1016/j.ultras.2013.07.007. Epub 2013 Jul 16.
- 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.
- Bos JD, Meinardi MM. The 500 Dalton rule for the skin penetration of chemical compounds and drugs. Exp Dermatol. 2000 Jun;9(3):165-9. doi: 10.1034/j.1600-0625.2000.009003165.x.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。