A Phase 1 interventional study of Uricase-PEG 20 in Gout and Hyperuricemia, sponsored by EnzymeRx. Status unknown at 2 sites in United States. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-12-24.
Sponsored by EnzymeRx · Phase 1, Interventional, and Treatment
The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single and multiple intramuscular doses of Uricase-PEG 20
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.
215 studies on the registry are indexed under Hyperuricemia; 40 are open to participants now.
This study's planned enrollment of 28 is below the median of 64 across 172 interventional studies indexed under Hyperuricemia.
Browse Hyperuricemia studies →EnzymeRx is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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)
Time frame: Up to 35 days after dosing
Pharmacokinetics (Uricase-PEG 20 serum concentration)
Time frame: Up to 35 days after dosing
Pharmacodynamics (plasma uric acid concentration)
Time frame: Up to 35 days after dosing
Immunogenicity
Time frame: Up to 35 days after dosing
This study is status unknown, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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