Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase

INcreased Flow Utilizing Subcutaneously-Enabled Fluids Administration Technique Study (INFUSE-AT): A Randomized, Open-Label, Parallel Group, Phase IV, Study Evaluating the Techniques of Administration of Subcutaneous Fluids Enabled by Human Recombinant Hyaluronidase (Hylenex) in Healthy Adult Volunteers

The purpose is to evaluate the ease of use and technical challenges encountered during subcutaneous infusion of Lactated Ringer's (LR) solution, preceded by recombinant human hyaluronidase (hylenex), utilizing commonly used angiocatheter gauges and button delivery systems. The safety and tolerability of hylenex-augmented SC infusion of LR through these delivery systems is also being evaluated.

Inclusion Criteria:

• male or female, aged 18 to 60 years
• intact normal skin without potentially obscuring features on both anterior thighs in the area intended for infusion
• agreeing to no fluid intake for 12 hours prior to start of study infusion
• vital signs within normal range or, if outside normal range, deemed not clinically significant
• metabolic panel, hematology, virology and standard 10-test urine dipstick tests within normal range, or if outside normal range, deemed not clinically significant
• if female of child-bearing potential,negative serum pregnancy tests
• negative urine drug screens
• written informed consent for participation

Exclusion Criteria:

• lower extremity edema
• lower extremity pathology that could interfere with study outcome
• history of cardiovascular disease
• rales on lung auscultation
• known allergy to hyaluronidase or other ingredient in the formulation of hylenex
• pregnancy or breast-feeding a child
• exposure to any experimental drug within 30 days prior to study participation
• previous participation in this study