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

Rheumatoid Arthritis Clinical Trial

Clinical Trial 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.

Clinical Trial Description

Sequential enrollment into four rHuPH20 dose cohorts. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00369187
Study type Interventional
Source Halozyme Therapeutics
Contact
Status Completed
Phase Phase 4
Start date July 2006
Completion date October 2006
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