Study of In-line Pressure Using Various Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (INFUSE-AT1A)

The INcreased Flow Utilizing Subcutaneously-Enabled Fluids Administration Technique 1A Study (INFUSE-AT 1A): A Randomized, Parallel Group Study to Evaluate the In-line Pressure, Flow Rate, Safety and Tolerability of Hylenex-facilitated Subcutaneous Fluid Administration In Healthy Volunteers Using Various Subcutaneous Infusion Techniques

The purpose is to characterize the in-line pressure profiles associated with several infusion technique factors during subcutaneous (SC) infusion of Lactated Ringer's solution, preceded by recombinant human hyaluronidase (hylenex). The safety and tolerability of hylenex-augmented SC infusion of Lactated Ringer's solution fluid is also being evaluated.

Inclusion Criteria:

• Male or female, aged 18 to 60 years, inclusive.
• Body mass index 19.0 to 35.0 kg/m2
• Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions on the upper back in the area intended for infusion
• Free from any clinically significant abnormality on the basis of medical/medication history or physical examination
• Vital signs and clinical laboratory parameters within normal range or, if outside normal range, deemed not clinically significant
• Negative urine drug and alcohol screens.

Exclusion Criteria:

• Upper back pathology that could interfere with study outcome.
• History of congestive heart failure, known coronary heart disease, active or recent pulmonary disease, or renal insufficiency.
• Rales on lung auscultation.
• Known allergy to hyaluronidase or any other ingredient in the formulation of hylenex recombinant
• Treatment with furosemide, benzodiazepines, or phenytoin.
• Pregnancy or breastfeeding.
• Exposure to any experimental drug within 30 days prior to study admission, or previous participation in this study.
• Any other reason which, in the investigator's opinion, would prevent the safe participation in the study.