Status:
COMPLETED
A Phase IIIB Dose Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer Subjects
Lead Sponsor:
Halozyme Therapeutics
Conditions:
Healthy
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief Summary
The purpose of this research study to test the effectiveness of a study medication to increase how fast a solution called lactated Ringer's is absorbed when put under the skin subcutaneously. The medi...
Detailed Description
The study will be conducted in two sequential stages: Stage 1: Preliminary assessment of mean flow rate and its inter-subject variability, and a comparison to IV infusion. Each subject will receive a...
Eligibility Criteria
Inclusion
- Males or females aged 18 to 60 years, inclusive
- Agreement that there will be no fluid intake for 12 hours prior to the start of the study infusion (except sips of water to take necessary medications)
- Vital signs (BP, HR, RR) within normal range
- Metabolic panel (e.g., sodium, potassium, chloride, bicarbonate, BUN, creatinine, glucose, calcium, AST, ALT, alkaline phosphatase, total bilirubin, albumin, and total protein) within normal range within 7 days of infusion
- Adequate venous access in at least one forearm
- A negative pregnancy test (if female of child-bearing potential) within 7 days of infusion
- Decision-making capacity
- Signed, written IRB-approved informed consent
Exclusion
- Extremity edema
- Upper extremity pathology that could interfere with study outcome (e.g., cellulitis, lymphatic disorder or prior surgery, pre-existing pain syndrome, previous mastectomy and/or axillary lymph node dissection, etc.)
- History of cardiovascular disease
- Rales on lung auscultation
- Known allergy to hyaluronidase or any other ingredient in the formulation of HYLENEX
- Known allergy to bee or vespid venom
- Known coagulopathy
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00311519
Start Date
November 1 2005
End Date
January 1 2006
Last Update
April 6 2006
Active Locations (1)
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1
West Coast Clinical Trials
Long Beach, California, United States, 90806-2325