Study of Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase

Study Overview
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Brief Summary
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The purpose is to evaluate the ease of use and technical challenges encountered during subcutaneous infusion of Lactated Ringer's (LR) solution, preceded by recombinant human hyaluronidase (hylenex), utilizing commonly used angiocatheter gauges and button delivery systems. The safety and tolerability of hylenex-augmented SC infusion of LR through these delivery systems is also being evaluated.

Official Title
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INcreased Flow Utilizing Subcutaneously-Enabled Fluids Administration Technique Study (INFUSE-AT): A Randomized, Open-Label, Parallel Group, Phase IV, Study Evaluating the Techniques of Administration of Subcutaneous Fluids Enabled by Human Recombinant Hyaluronidase (Hylenex) in Healthy Adult Volunteers

Conditions
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Dehydration

Intervention / Treatment
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* Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: male or female, aged 18 to 60 years intact normal skin without potentially obscuring features on both anterior thighs in the area intended for infusion agreeing to no fluid intake for 12 hours prior to start of study infusion vital signs within normal range or, if outside normal range, deemed not clinically significant metabolic panel, hematology, virology and standard 10-test urine dipstick tests within normal range, or if outside normal range, deemed not clinically significant if female of child-bearing potential,negative serum pregnancy tests negative urine drug screens written informed consent for participation Exclusion Criteria: lower extremity edema lower extremity pathology that could interfere with study outcome history of cardiovascular disease rales on lung auscultation known allergy to hyaluronidase or other ingredient in the formulation of hylenex pregnancy or breast-feeding a child exposure to any experimental drug within 30 days prior to study participation previous participation in this study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tegaderm-secured 24 ga Teflon catheter<br>subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, Teflon angiocatheter secured with Tegaderm | Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion<br>* single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution<br>* Other names: LR solution;|
| Experimental: Tape-secured 24 ga Teflon catheter<br>subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, Teflon angiocatheter secured with a tape double chevron | Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion<br>* single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution<br>* Other names: LR solution;|
| Experimental: Tegaderm-secured 24 ga polyurethane catheter<br>subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, polyurethane angiocatheter secured with Tegaderm | Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion<br>* single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution<br>* Other names: LR solution;|
| Experimental: Tape-secured 24 ga polyurethane catheter<br>subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 24-gauge, 0.75 inch long, polyurethane angiocatheter secured with a tape double chevron | Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion<br>* single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution<br>* Other names: LR solution;|
| Experimental: Tegaderm-secured 20 ga Teflon catheter<br>subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, Teflon angiocatheter secured with Tegaderm | Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion<br>* single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution<br>* Other names: LR solution;|
| Experimental: Tape-secured 20 ga Teflon catheter<br>subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, Teflon angiocatheter secured with a tape double chevron | Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion<br>* single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution<br>* Other names: LR solution;|
| Experimental: Tegaderm-secured 20 ga polyurethane catheter<br>subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, polyurethane angiocatheter secured with Tegaderm | Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion<br>* single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution<br>* Other names: LR solution;|
| Experimental: Tape-secured 20 ga polyurethane catheter<br>subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a 20-gauge, 1.0 inch long, polyurethane angiocatheter secured with a tape double chevron | Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion<br>* single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution<br>* Other names: LR solution;|
| Experimental: SC button with 27 ga X 9 mm needle<br>subcutaneous administration of a single 150 U dose of hylenex, followed by subcutaneous infusion (delivered by large volume infusion pump) of 1000 mL Lactated Ringer's solution, both delivered through a button-type subcutaneous delivery system (with a 27-gauge, 9 mm long metal needle) | Drug: hylenex-facilitated subcutaneous Lactated Ringer's infusion<br>* single subcutaneous 150 U dose of hylenex, followed by subcutaneous infusion of 1000 mL Lactated Ringer's solution<br>* Other names: LR solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Challenges | Protocol-specified challenges encountered during subcutaneous (SC) hylenex administration and/or SC infusion of Lactated Ringer's solution, including SC catheter kinking, catheter/button dislodgement, catheter/button pull-out, infusion pump alarm, other pump failure, healthcare provider intervention to secure/maintain SC infusion eg, re-taping, catheter/button manipulation, etc, and any other type of technical challenge encountered | throughout subcutaneous hylenex and fluid administration period (continuous) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attempts Needed to Successfully Place Subcutaneous Catheter/Button |  | from start of first attempt until completion of catheter/button placement | 
| Time Needed to Successfully Place Subcutaneous Catheter/Button |  | from start of first attempt until completion of catheter/button placement | 
| Time Required to Infuse 1000 mL Fluid |  | from start of Lactated Ringer's (LR) infusion until 1000 mL LR infused | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dehydration, fluid therapy, hyaluronoglucosaminidase, hyaluronidase, hypodermoclysis, clysis, subcutaneous hydration, subcutaneous rehydration, hyaluronan, rHuPH20