drugset / Trial / NCT00656370
Study of Subcutaneous Hydration Enabled by Human Recombinant Hyaluronidase (Hylenex)
RandomizedParallel-groupQuadruple-blindTreatment
Summary
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.
Timeline
- Start
- 2007-12
- Primary completion
- 2008-01-30
- Completion
- 2008-01-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | rHuPH20 | Protein / enzyme biologic | 150 iu | Subcutaneous |
Indications
No indication recorded.