Healthy Volunteers Clinical Trial
Official title:
Clinical Study of the BD Evolve™ On-body Injector's Adherence Performance on the Arm Over 28 Hours of Wear
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.
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. ;
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