Safety and Efficacy Study of Intramuscular Uricase-PEG 20
Märksõnad
Abstraktne
Kirjeldus
Uricase is an enzyme (found in most mammals but not humans) that converts poorly soluble uric acid into highly soluble allantoin. Because humans lack uricase, they are prone to develop elevated levels of uric acid, which can form crystals in the joints and soft tissues. In those which chronically elevated uric acid, gout may develop. In the setting of acute rises in uric acid, seen for example in tumor lysis syndrome, uric acid crystals can damage the renal tubules. Uricase-PEG 20 is a recombinant uricase conjugated with multiple PEG molecules designed to prolong the half-life and decrease the immunogenicity of uricase. This study will characterize the safety, pharmacokinetics and pharmacodynamics of intramuscular Uricase-PEG 20, the anticipated route of administration to be used in future clinical development in gout.
Kuupäevad
| Viimati kinnitatud: | 11/30/2009 |
| Esmalt esitatud: | 12/21/2009 |
| Hinnanguline registreerumine on esitatud: | 12/21/2009 |
| Esmalt postitatud: | 12/23/2009 |
| Viimane värskendus on esitatud: | 12/21/2009 |
| Viimati värskendus postitatud: | 12/23/2009 |
| Õppe tegelik alguskuupäev: | 11/30/2009 |
| Eeldatav esmane lõpetamise kuupäev: | 03/31/2010 |
| Eeldatav uuringu lõpetamise kuupäev: | 04/30/2010 |
Seisund või haigus
Sekkumine / ravi
Biological: Uricase-PEG 20
Faas
Käerühmad
| Arm | Sekkumine / ravi |
|---|---|
| Experimental: Uricase-PEG 20 Cohorts will receive ascending doses of Uricase-PEG 20 in a sequential manner. The study will enroll both single dose cohorts and multi-dose cohorts. | Biological: Uricase-PEG 20 Intramuscular injection of Uricase-PEG 20 without premedication |
Abikõlblikkuse kriteeriumid
| Õppimiseks sobivad vanused | 40 Years To 40 Years |
| Uuringuks kõlblikud sood | All |
| Võtab vastu tervislikke vabatahtlikke | Jah |
| Kriteeriumid | Inclusion Criteria: - Serum uric acid > 6 mg/dL (men) or > 5 mg/dL (women) - Clinical laboratory values within normal limits or not clinically significant - Women should be menopausal or peri-menopausal Exclusion Criteria: - Prior exposure to uricase - History of severe allergic reactions, or any allergy to PEG or pegylated products - G6PD or catalase deficiency - Medical condition that may interfere with ability to complete the study (e.g., uncontrolled diabetes or hypertension, congestive heart failure NYHA Class III or IV, history of myocardial infarction, immunosuppression, pregnancy) |
Tulemus
Esmased tulemusnäitajad
1. Safety (assessment of signs and symptoms and clinical laboratory measurements following administration of Uricase-PEG 20, graded according to the Common Toxicity Criteria for Rheumatology, version 2.0) [Up to 35 days after dosing]
Sekundaarsed tulemusmõõdud
1. Pharmacokinetics (Uricase-PEG 20 serum concentration) [Up to 35 days after dosing]
2. Pharmacodynamics (plasma uric acid concentration) [Up to 35 days after dosing]
3. Immunogenicity [Up to 35 days after dosing]
