Investigational On-body Injector Clinical Study

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Device: In-clinic wear first; Device: Home wear first

• Registration Number: NCT05553418
• Lead Sponsor: Becton, Dickinson and Company

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.

Study Timeline

• Study First Submitted: 2022-07-15
• Study Start: 2022-09-05
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-23
• Primary Completion: 2023-02-08
• Study Completion: 2023-02-08
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-17
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
"In-Clinic wear first"	In-clinic wear first	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.
"Home wear first"	Home wear first	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

Primary Outcome Measures

Name	Time	Method
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)
Device Performance - Dose delivery efficiency	After device removal	Determined by volume - measured via gravimetric analysis (weighing the device)

Secondary Outcome Measures

Name	Time	Method
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
Additional OBI performance - Catheter condition	Approximately 15-minutes after device removal	Catheter bending assessment by grading
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
Ultrasound Imaging of injection site	Baseline and immediately after procedure for each applied device	Measure pre- and post-injection tissue thickness
Adverse Events	Throughout study completion, an average of 4 week	Incidence of adverse device effects and procedure related adverse events
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.
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

Trial Locations

Locations (1)

Eurofins Optimed; 🇫🇷 Gières, France