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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2008-01-30

Brief Summary

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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.

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Detailed Description

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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 recombinant hyaluronidase (hylenex) 150 units. The study will be conducted in two sequential stages.

In Stage 1, the comparison will be NS solution to LR solution. Each subject will receive simultaneous SC infusions of 500 mL (from a 500 mL bag) of solution in each anterior thigh, consisting of NS in one thigh and LR in the other thigh. The thighs (left vs. right) to receive NS and LR will be randomized and double blinded. Immediately prior to the infusions, each thigh will have 150 units of hylenex simultaneously injected.

Tolerability will be assessed based on the subject's self-assessment of discomfort on a visual analog scale (VAS). Safety will be assessed by physical examination targeted at infusion sites, vital signs, and adverse events. The amount of fluid infused will be assessed by weighing the infusion bag, fluid and tubing at designated time points, and allowing the determination of flow rate.

Stage 2 will be conducted only if the observed Stage 1 VAS mean maximum pain score is at least 25 mm higher for one solution compared to the other. Stage 2 will evaluate the tolerability, safety, and flow rates of subcutaneously infused NS solution and buffered NS solution.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NS Infusion Group

Normal Saline (NS) and Hylenex

Group Type EXPERIMENTAL

recombinant human hyaluronidase

Intervention Type DRUG

150 Units in 1mL

LR Infusion Group

Lactated Ringer's (LR) and Hylenex

Group Type EXPERIMENTAL

recombinant human hyaluronidase

Intervention Type DRUG

150 Units in 1mL

Interventions

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recombinant human hyaluronidase

150 Units in 1mL

Intervention Type DRUG

Other Intervention Names

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Hylenex

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes