A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase
This Phase I, randomized, double-blinded, within-subject controlled, two-way crossover study comparing the time to inject (flow rate), safety, and tolerability of a subcutaneously (SC) administered, viscous antibody solution of with and without human recombinant hyaluronidase (rHuPH20) in volunteer subjects.
The study hypothesizes that the time required to complete a 20-mL SC injection of a viscous antibody with rHuPH20 will be comparable or shorter than the time required for the injection without rHuPH20.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Health Services Research
|Official Title:||Phase I Dose-Ranging Randomized Double-Blinded Controlled Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase|
- The time to inject 20 mL of a viscous antibody solution with and without rHuPH20.
- Assess the time required for a subcutaneous injection with various doses of rHuPH20, safety, tolerability.
|Study Start Date:||February 2007|
|Study Completion Date:||May 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00435604
|Principal Investigator:||Anoshie Ratnayake, M.D.||Principal Investigator|