Interrogating Subcutaneous Injection Delivery Systems Using Translational Preclinical and Clinical Models. Including the Case Study: Clinical Evaluation of an Investigational 5 mL Wearable Injector

Learnings from preclinical and clinical translational studies using fluoroscopic (preclinical) or ultrasound (clinical) in situ imaging to characterize 0.6-10 mL, 1-50 cP subcutaneous injections delivered by a surrogate pump or an investigational on-body injector
Session Outline:  

• Assess the feasibility and/or the tolerability (clinical only) of SC injections up to 10 mL & 50 cP  

• Provide detailed in situ device and depot imagery to reveal what happens beneath the skin surface during drug delivery

• Explore the relationship between visible tissue effects and underlying depots

• Qualify and quantify the impact of ambulatory wear on wearable and on-body injector performance and the corresponding tissue effects and subject perception (wearable injector only)