Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex)

Completed · Phase 4

Conditions studied: Healthy

In brief

Randomized, double-blinded study that will evaluate the tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and preceded by human recombinant hyaluronidase (hylenex) 150 units. In Stage 1, the comparison will be Normal Saline (NS) solution to Lactated Ringer's (LR) solution. Each subject will receive 500 milliliters (mL) of solution, consisting of NS in one thigh and LR in the other thigh. Immediately prior to the infusions, each thigh will have 150 units of hylenex. In Stage 2, the comparison will be NS solution and buffered NS solution.

Key facts

Study ID: NCT00656370
Run by: Halozyme Therapeutics
People needed: 15
Starts: 2007-12-01
Expected to finish: 2008-01-30
Last updated by the study team: 2018-10-17

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Male or female, 18 to 60 years of age.
Intact normal skin without in the areas intended for infusion.
No fluid intake for 12 hours prior to the start of the study infusion.
Vital signs (Blood Pressure (BP), Heart Rate (HR), Respiratory Rate (RR)) within normal range.
Metabolic panel within normal range.
A negative urine or serum pregnancy test.
Signed, written Institutional Review Board (IRB)-approved informed consent.

You may not qualify if…

Lower extremity edema.
Lower extremity pathology that could interfere with study outcome.
Rales on lung auscultation.
History of cardiovascular disease.
Allergy to hyaluronidase.
Allergy to bee or vespid venom.
Pregnancy or breast-feeding woman.
Use of any investigational drug or device within 30 days of enrollment.

Where it is running

Jasper Clinic — Kalamazoo, Michigan, United States

Full record on ClinicalTrials.gov

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