Study of a Large Protein Molecule Administered With Escalating Doses of Recombinant Human Hyaluronidase
Status:
Completed
Trial end date:
2006-10-01
Target enrollment:
Participant gender:
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.