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.

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.

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.