BD announced the publication of the results from a 52-subject human clinical trial with the BD Libertas Wearable Injector.
FREMONT, CA: BD (Becton, Dickinson, and Company), a leading global medical technology company, publishes the results from a 52-subject human clinical trial with the BD Libertas Wearable Injector. The subcutaneous drug delivery system, presently in the final phases of development, is developed as ready to use and deliver drugs such as biologics with viscosities up to 50 cP in 2-5 mL and 5-10 mL configurations.
This research to assess the performance of the 5 mL BD Libertas device in human subjects, including tissue effects, skin reactivity, and patient acceptance, confirms that the BD Libertas device offered within an acceptable period 5 mL of 8 cP injections to the abdomen and thigh regardless of subject age, gender, or BMI and with/without patient movement. The application, use, and removal of the injector were found to be acceptable, and subjects were likely to use the BD Libertas Wearable Injector if prescribed. No severe wheal, erythema, or bleeding was found, and no unacceptable pain was noted at 24 hours post-injection.
The study represents the recent in a series of over 50 BD-conducted pre-clinical and clinical studies intended to inform the design and measure the performance of the BD Libertas Wearable Injector, demonstrate the feasibility of 2-10 mL biologic injections into the subcutaneous tissue, and characterize tissue response to large volume injections in human and animal subjects. These results show that BD Libertas Wearable Injector effectively provides dose volumes up to 5 mL subcutaneously and may be leveraged by our pharmaceutical partners as a reliable platform for large volume delivery. BD is committed to working with its customers and the broader pharmaceutical market to meet their needs by allowing an expanded drug delivery design space.
Pharmaceutical companies are now developing biologics for subcutaneous delivery in larger dose volumes to help life cycle management of therapies, including migration from intravenous to subcutaneous administration routes. BD undertook this study, recognizing that limited clinical evidence exists in the public domain to support injection feasibility and tolerability with wearable injector solutions to deliver larger dose volumes.