Status:
COMPLETED
Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex)
Lead Sponsor:
Halozyme Therapeutics
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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...
Detailed Description
This Phase IV, randomized, double-blinded study in volunteer subjects to evaluate the tolerability, safety, and flow rates of different solutions subcutaneously (SC) infused and preceded by human reco...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00656370
Start Date
December 1 2007
End Date
January 30 2008
Last Update
October 17 2018
Active Locations (1)
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1
Jasper Clinic
Kalamazoo, Michigan, United States, 49007