BD Evolve™ On-body Injector's Adherence Performance - Wear Study

Becton, Dickinson and Company (BD)

Status: Completed

Conditions: Healthy Volunteers

Treatments: Device: Device wear on skin

Study type: Interventional

Funder types: Industry

Identifiers

NCT06247644

PHS-23OBI03

Details and patient eligibility

About

An On-body Injector is a small device, which is adhered to the skin with a sticky patch. The injector is intended to deliver a small volume of medicine from a reservoir inside the device into the skin via a small catheter. The drug delivery happens after a period of time, as programmed into the device, and afterwards the device can be removed.

The purpose of this study is to evaluate how well the BD Evolve™ On-body Injector adhesive pad sticks to the skin and how the adhesive keeps the device in position when worn on the arm during normal daily activities for 28 hours. As this study only evaluates the performance of the adhesive pad of the OBI, no injection will be performed, and the device will not be filled with any fluid. The injection capability will be disabled.

Full description

The BD Evolve™ On-body Injector (OBI) is being developed as a platform drug delivery device for use with a class or family of drug products approved for subcutaneous injections. It is a small, fill-at-use device based on a core BD technology for wearable pump drug delivery systems.

The OBI is a sterile, single-use, single-dose, disposable wearable pump injector that delivers a fixed dose of 0.6ml of drug approximately 27 hours after the device is activated; the dose will be delivered subcutaneously over a duration of 35 minutes in the home environment.

The purpose of this study is to assess the adherence performances (adhesive pad to participants' skin and heat stake) of the BD Evolve™ On-body injector (OBI) when worn on the arm for 28 hours, under normal daily activities in generally healthy human subjects, with and without use of an additional adhesive ring. Cutaneous tissue effects associated with wear of the OBI device, with and without use of an additional adhesive ring, will also be assessed.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male or female participants ≥ 18 years of age, at the time of signing the informed consent, without evidence of acute illness.
2. Participant with a BMI ≥18.5 kg/m2.
3. Participant able to read, write, and understand English.
4. Participant willing and able to complete all required study procedures.
5. Participant willing and able to wear a loose-fitting, short sleeved shirt during each of the two study visits.
6. Participant willing to have hair clipped at the application site if deemed necessary by the investigator.
7. Provision of signed and dated informed consent form.

Exclusion criteria

1. Participants who have applied lotions, creams, oils, or similar products to the arm on study days.
2. Participants who are pregnant or breast-feeding (self-reported).
3. Participants with any self-reported uncontrolled chronic illness (heart disease, respiratory disease, kidney disease, metabolic diseases etc.).
4. Participants with treatment interfering with the coagulation system (e.g. anticoagulants), agents decreasing platelet function (e.g. aspirin) or reducing platelet count (thrombocytopenia due to long-term usage of beta-lactam antibiotics and sulfamethoxazole), within 12 hours of and during an in-clinic visit.
5. Participants undergoing peeling, laser treatment or dermabrasion on the arms.
6. Participants who have tattoos, skin issues or infection at the application sites, including, but not limited to ulceration, blister, inflammation, extensive scarring or callous, swelling or healed burns (to be verified by study HCP).
7. Participants with current visible skin disease, inflammation or infection (e.g. acne, herpes), hyperkeratosis (e.g. psoriasis, chronic eczema) on the arm and/or redundant skin (e.g. participants with significant weight loss).
8. Participants with any history of skin sensitivity, including reactions to adhesive such as those in skin bandages or skin tape (particularly acrylic adhesive).
9. Participants who have a known latex allergy.
10. Participants not willing to shave long hairs from their arm before application.
11. Participants who are unwilling to be photographed as required by the study.
12. Participants suspected to have non-compliance with the study procedures and/or of non-completion of the study according to the investigator's judgment.
13. Participants with evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator's opinion, would cause the individual to be noncompliant.
14. Participants under administrative or legal supervision.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

128 participants in 2 patient groups

Arm 1 - On-body Injector (OBI) - only

Experimental group

Description:

Adhesion of device with adhesive on left or right upper arm

Treatment:

Device: Device wear on skin

Arm 2 - OBI + additional adhesive ring

Experimental group

Description:

Adhesion of device with adhesive on left or right upper arm + additional adhesive ring to be placed additional on the skin.

Treatment:

Device: Device wear on skin