Study of a Large Protein Molecule Administered With Escalating Doses of Recombinant Human Hyaluronidase

Summary

This Phase IV, dose escalation, within-patient controlled study of pharmacokinetics (PK), safety and tolerability compares a single dose administration of a large protein molecule without recombinant human hyaluronidase (rHuPH20) to a single dose administration of the large molecule with escalating doses of rHuPH20. The study hypothesizes that an optimal dose of rHuPH20 will increase the bioavailability of large molecule drug administration.

Timeline

Start

2006-07

Primary completion

—

Completion

2006-10

Drugs

Indications