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Sponsored by: |
Halozyme Therapeutics |
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Information provided by: | Halozyme Therapeutics |
ClinicalTrials.gov Identifier: | NCT00369187 |
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.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: large protein molecule |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Pharmacokinetics Study |
Estimated Enrollment: | 15 |
Study Start Date: | July 2006 |
Study Completion Date: | October 2006 |
Sequential enrollment into four rHuPH20 dose cohorts.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Males or females at least 18 years of age with RA treated with MTX who have been treated with:
Exclusion Criteria:
Study ID Numbers: | HZ2-06-02 |
Study First Received: | August 25, 2006 |
Last Updated: | January 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00369187 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |
Autoimmune Diseases Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases |