NCT05553418

Investigational On-body Injector Clinical Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DEVICE	In-clinic wear first	Participant will remain in clinic and wear devices adhered on abdomen or arm approximately 27hrs prior to 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.

Timeline

• Start date: 2022-09-05
• Primary completion: 2023-02-08
• Completion: 2023-02-08
• First posted: 2022-09-23
• Last updated: 2025-02-03

Locations

1 site across 1 country: France