Study of a Large Protein Molecule Administered With Escalating Doses of Recombinant Human Hyaluronidase
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
- Tmax, Cmax, half-lives, injection site reactions, safety and tolerability, NAbs
|Study Start Date:||July 2006|
|Study Completion Date:||October 2006|
Sequential enrollment into four rHuPH20 dose cohorts.