Investigational On-body Injector Clinical Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the clinical feasibility, performance, safety and acceptability of the On-body Injector (OBI) when applied to the arm or abdomen of healthy volunteers to inject placebo under the skin.

Detailed Description
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This study is a monocentric, open-label, cross-over, feasibility and exploratory study with no acceptance criteria. Up to 70 healthy volunteers will be enrolled and followed up for 7 weeks at maximum.

Official Title
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BD Evolve On-body Injector: Clinical Feasibility and Performance in the Abdomen and Arm

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Device: In-clinic wear first
* Device: Home wear first


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult participants ≥ 18 years BMI ≥18.5 kg/m2 Participant willing and able to complete all required study procedures and to provide informed consent Exclusion Criteria: Participant any self-reported existing chronic illness (heart disease, respiratory disease, kidney disease, metabolic diseases etc.). Participants with treatment interfering with coagulation, platelet function, or pain perception within 12 hrs of in-clinic visit Participants with abdominal or arm skin conditions or treatments that may interfere with planned study treatment Participants with acute or chronic hepatitis B or C and/or with known history/positive HIV serology. Participants who are pregnant, planning to become pregnant, or are breast-feeding.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All participants will participate in three (3) study arms, whereby each participant will wear six (6) OBI prototype devices in total: three (3) on the arm and three (3) on the abdomen. A randomization scheme will be provided with the order of study arm + body location (arm/abdomen) + body side (left/right) randomized.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: In-Clinic wear first<br>Participant will wear the devices first during 27 hr in-clinic wear first followed by injection, then a short-term wear period in-clinic followed by injection, and finally at home for 27 hrs followed by injection. | Device: In-clinic wear first<br>* Participant will remain in clinic and wear devices adhered on abdomen or arm approximately 27hrs prior to injection<br>|
| Experimental: Home wear first<br>Participant will wear the devices at home first with return to clinic for injection, followed by a short-term wear period in-clinic for injection, and finally during a 27hr in-clinic stay for injection | Device: Home wear first<br>* Device will be applied to the abdomen or arm to deliver placebo subcutaneously. After device application, participant will go home and return to clinic before delivery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Performance - Dose delivery efficiency | Determined by volume - measured via gravimetric analysis (weighing the device) | After device removal | 
| Device Performance | Change in adhesive pad adherence - device to skin/device to adhesive pad - determined via adherence scales (Score 0 - 4, whereby 0 is full adherence and 4 is reflecting full detachment) | From device application until 15-minutes after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional OBI performance - Injection signal/indicator performance | Assessed by visual or audible observation from activation to injection end. | Before, during and after injection for each applied device; up to 28 hours after application | 
| Additional OBI performance - Catheter condition | Catheter bending assessment by grading | Approximately 15-minutes after device removal | 
| Participant Pain | 100mm Visual Analog Scale (VAS) for pain assessment - describing no pain with 0mm - up to worst possible pain described with 100mm | Immediately before device catheter is inserted, after insertion, during wear period, at start of injection, 15 minutes after injection, end of injection and upon removal for each applied device | 
| Participant Acceptability Questionnaires | Questionnaires to assess participants' acceptability of the device during wear | Device acceptability questionnaire will be completed after device catheter is inserted, at 8 hours and 26 hrs after application, during Injection and upon device removal | 
| Ultrasound Imaging of injection site | Measure pre- and post-injection tissue thickness | Baseline and immediately after procedure for each applied device | 
| Tissue Effects | Assessment of wheal and erythema described via grading 0-4, incidence of bleeding, bruising, induration | Baseline, immediately after procedure, follow up check up to 72 hours after injection in case tissue effects are present | 
| Adverse Events | Incidence of adverse device effects and procedure related adverse events | Throughout study completion, an average of 4 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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On-Body Injector