Investigational On-body Injector Clinical Study

Becton, Dickinson and Company70 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

In-clinic wear firstDEVICE

Participant will remain in clinic and wear devices adhered on abdomen or arm approximately 27hrs prior to injection

Home wear firstDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Eurofins Optimed

Gières, France

Outcomes

Primary Outcomes

Device Performance - Dose delivery efficiency

Determined by volume - measured via gravimetric analysis (weighing the device)

Time frame: 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)

Time frame: From device application until 15-minutes after injection

Secondary Outcomes

Additional OBI performance - Injection signal/indicator performance

Assessed by visual or audible observation from activation to injection end.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Data from ClinicalTrials.gov

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