BD (Becton, Dickinson and Company) has announced the completion of a 50-subject human clinical trial for its BD Libertas Wearable Injector.
The device is a subcutaneous drug delivery system, designed to require no patient assembly and deliver biologics with viscosities up to 50 cP in 2-5 mL and 5-10 mL configurations.
The study, independently sponsored and conducted by BD, intended to evaluate the device’s performance in human subjects, assessing things such as tissue effects, skin reactivity and patient acceptance. The results are expected to be announced early 2020.
The study is the most recent in a series of more than 50 pre-clinical and clinical studies conducted by BD and intended to measure the performance of the BD Libertas Wearable Injector, demonstrate the feasibility of 2-10 mL biologic injections into subcutaneous tissue and characterize the tissue response to large volume injections in both animal and human subjects.
Commenting on the study, Peter Nolan, Worldwide President of BD Pharmaceutical Systems, said: “BD is committed to bringing value to our pharma partnerships, including providing them with independent BD sponsored and generated study data to accelerate combination product development.”
“The recent study reflects BD’s continued investment in solutions to meet pharma’s needs by expanding the design space for biologics delivery.”