A Study of the Subcutaneous Injection of a Viscous Antibody Solution With Recombinant Human Hyaluronidase

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.

Timeline

Start

2007-02

Primary completion

—

Completion

2007-05

Drugs

Indications

No indication recorded.