Clinical trial NCT05553418: Investigational On-body Injector Clinical Study
Official title: BD Evolve On-body Injector: Clinical Feasibility and Performance in the Abdomen and Arm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: On-Body Injector
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2022-09-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Device Performance - Dose delivery efficiency
timeFrame: After device removal
measure: Device Performance
timeFrame: From device application until 15-minutes after injection
Secondary outcomes:
measure: Additional OBI performance - Injection signal/indicator performance
timeFrame: Before, during and after injection for each applied device; up to 28 hours after application
measure: Additional OBI performance - Catheter condition
timeFrame: Approximately 15-minutes after device removal
measure: Participant Pain
timeFrame: 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
measure: Participant Acceptability Questionnaires
timeFrame: 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
measure: Ultrasound Imaging of injection site
timeFrame: Baseline and immediately after procedure for each applied device
measure: Tissue Effects
timeFrame: Baseline, immediately after procedure, follow up check up to 72 hours after injection in case tissue effects are present
measure: Adverse Events
timeFrame: Throughout study completion, an average of 4 week
Other outcomes:
Locations:
city: Gières
country: France
facility: Eurofins Optimed
Study officials:
affiliation: Eurofins
name: Yves Donazzolo, MD
role: PRINCIPAL_INVESTIGATOR
References: