A Phase IIIB Dose Comparison Study of Subcutaneous Hydration With and Without Human Recombinant Hyaluronidase (HYLENEX) in Volunteer Subjects

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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 medication to be studied is an enzyme called hyaluronidase, and is a human recombinant form of the enzyme. The drug company name for this medication is Hylenex. Hylenex was currently an investigational medication at the initiation of the study, but received FDA approval during the study. An investigational medication is a medication or formulation of a medication that is not approved by the United States Food and Drug Administration for use in this country but may be used in studies such as this one.

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

Details

• Lead Sponsor: Halozyme Therapeutics

Criteria

Inclusion Criteria:

1. Males or females aged 18 to 60 years, inclusive

2. 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)

3. Vital signs (BP, HR, RR) within normal range

4. 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

5. Adequate venous access in at least one forearm

6. A negative pregnancy test (if female of child-bearing potential) within 7 days of infusion

7. Decision-making capacity

8. Signed, written IRB-approved informed consent

Exclusion Criteria:

1. Extremity edema

2. 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.)

3. History of cardiovascular disease

4. Rales on lung auscultation

5. Known allergy to hyaluronidase or any other ingredient in the formulation of HYLENEX

6. Known allergy to bee or vespid venom

7. Known coagulopathy