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

• Status: Terminated
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Baxter Healthcare Corporation
• Collaborator: Halozyme Therapeutics
• Treatments: Pharmaceutical Solutions

Criteria

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.