A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase
Status:
Completed
Trial end date:
2007-05-01
Target enrollment:
Participant gender:
Summary
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.