A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00435604|
Recruitment Status : Completed
First Posted : February 15, 2007
Last Update Posted : October 17, 2011
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: Hylenex||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|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|
|Study Start Date :||February 2007|
|Actual Study Completion Date :||May 2007|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00435604
|Principal Investigator:||Anoshie Ratnayake, M.D.||Principal Investigator|