Gout, Hyperuricemia
Conditions
Brief summary
The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single and multiple intramuscular doses of Uricase-PEG 20
Detailed description
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.
Interventions
BIOLOGICALUricase-PEG 20
Intramuscular injection of Uricase-PEG 20 without premedication
Sponsors
EnzymeRx
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics (Uricase-PEG 20 serum concentration) | Up to 35 days after dosing |
| Pharmacodynamics (plasma uric acid concentration) | Up to 35 days after dosing |
| Immunogenicity | Up to 35 days after dosing |
Countries
United States
Contacts
Primary ContactRocelle Flores
Outcome results
None listed