Investigational On-body Injector Clinical Study

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: In-clinic wear first; Device: Home wear first

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 Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Natasha Bolick; Phone Number: 0019842016254; Email: Natasha.Bolick@bd.com

Study Locations

• France
  • Gières, France
    • Eurofins Optimed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: "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.	Device: In-clinic wear first; Participant will remain in clinic and wear devices adhered on abdomen or arm approximately 27hrs prior to injection
Experimental: "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	Device: Home 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company
• Investigators: Principal Investigator: Yves Donazzolo, MD, Eurofins

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2022
• Primary Completion (Actual): February 8, 2023
• Study Completion (Actual): February 8, 2023

Study Registration Dates

• First Submitted: July 15, 2022
• First Submitted That Met QC Criteria: September 21, 2022
• First Posted (Actual): September 23, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: On-Body Injector
• Other Study ID Numbers: PHS-20OBI01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No