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

• Status: Completed
• Trial end date: 2008-01-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Halozyme Therapeutics
• Collaborator: Baxter Healthcare Corporation

Criteria

Inclusion Criteria:

1. Male or female, 18 to 60 years of age.

2. Intact normal skin without in the areas intended for infusion.

3. No fluid intake for 12 hours prior to the start of the study infusion.

4. Vital signs (Blood Pressure (BP), Heart Rate (HR), Respiratory Rate (RR)) within normal range.

5. Metabolic panel within normal range.

6. A negative urine or serum pregnancy test.

7. Signed, written Institutional Review Board (IRB)-approved informed consent.

Exclusion Criteria:

1. Lower extremity edema.

2. Lower extremity pathology that could interfere with study outcome.

3. Rales on lung auscultation.

4. History of cardiovascular disease.

5. Allergy to hyaluronidase.

6. Allergy to bee or vespid venom.

7. Pregnancy or breast-feeding woman.

8. Use of any investigational drug or device within 30 days of enrollment.