Healthy Volunteers
Conditions
Keywords
On-Body Injector
Brief summary
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
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.
Interventions
DEVICEIn-clinic wear first
Participant will remain in clinic and wear devices adhered on abdomen or arm approximately 27hrs prior to injection
DEVICEHome wear first
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.
Sponsors
Becton, Dickinson and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Performance - Dose delivery efficiency | After device removal | Determined by volume - measured via gravimetric analysis (weighing the device) |
| Device Performance | From device application until 15-minutes after injection | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participant Pain | 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 | 100mm Visual Analog Scale (VAS) for pain assessment - describing no pain with 0mm - up to worst possible pain described with 100mm |
| Participant Acceptability Questionnaires | 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 | Questionnaires to assess participants' acceptability of the device during wear |
| Additional OBI performance - Injection signal/indicator performance | Before, during and after injection for each applied device; up to 28 hours after application | Assessed by visual or audible observation from activation to injection end. |
| Tissue Effects | Baseline, immediately after procedure, follow up check up to 72 hours after injection in case tissue effects are present | Assessment of wheal and erythema described via grading 0-4, incidence of bleeding, bruising, induration |
| Adverse Events | Throughout study completion, an average of 4 week | Incidence of adverse device effects and procedure related adverse events |
| Ultrasound Imaging of injection site | Baseline and immediately after procedure for each applied device | Measure pre- and post-injection tissue thickness |
| Additional OBI performance - Catheter condition | Approximately 15-minutes after device removal | Catheter bending assessment by grading |
Countries
France
Outcome results
None listed