Investigational On-body Injector Clinical Study

Becton, Dickinson and Company (BD)

Status: Completed

Conditions: Healthy Volunteers

Treatments: Device: In-clinic wear first; Device: Home wear first

Study type: Interventional

Funder types: Industry

Identifiers

NCT05553418

PHS-20OBI01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

"In-Clinic wear first"

Experimental group

Description:

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.

Treatment:

Device: In-clinic wear first

"Home wear first"

Experimental group

Description:

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

Treatment:

Device: Home wear first