Study of In-line Pressure Using Various Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (INFUSE-AT1A)
Stopped early · Phase 4
Conditions studied: Dehydration
In brief
The purpose is to characterize the in-line pressure profiles associated with several infusion technique factors during subcutaneous (SC) infusion of Lactated Ringer's solution, preceded by recombinant human hyaluronidase (hylenex). The safety and tolerability of hylenex-augmented SC infusion of Lactated Ringer's solution fluid is also being evaluated.
Key facts
- Study ID
- NCT01116102
- Run by
- Baxter Healthcare Corporation
- People needed
- 20
- Starts
- 2010-05-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2011-10-24
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female, aged 18 to 60 years, inclusive.
- Body mass index 19.0 to 35.0 kg/m2
- Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions on the upper back in the area intended for infusion
- Free from any clinically significant abnormality on the basis of medical/medication history or physical examination
- Vital signs and clinical laboratory parameters within normal range or, if outside normal range, deemed not clinically significant
- Negative urine drug and alcohol screens.
You may not qualify if…
- Upper back pathology that could interfere with study outcome.
- History of congestive heart failure, known coronary heart disease, active or recent pulmonary disease, or renal insufficiency.
- Rales on lung auscultation.
- Known allergy to hyaluronidase or any other ingredient in the formulation of hylenex recombinant
- Treatment with furosemide, benzodiazepines, or phenytoin.
- Pregnancy or breastfeeding.
- Exposure to any experimental drug within 30 days prior to study admission, or previous participation in this study.
- Any other reason which, in the investigator's opinion, would prevent the safe participation in the study.
Where it is running
- Kendle International, Inc. Drug Study Unit — Morgantown, West Virginia, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.