Overview

This trial is active, not recruiting.

Conditions gout, hyperuricemia
Treatment uricase-peg 20
Phase phase 1
Sponsor EnzymeRx
Start date October 2009
End date March 2010
Trial size 20 participants
Trial identifier NCT01021241, ENZ-101

Summary

The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single intravenous doses of Uricase-PEG 20.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification pharmacokinetics/dynamics study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Cohorts will receive ascending doses of Uricase-PEG 20 in a sequential manner
uricase-peg 20
Intravenous infusion of Uricase-PEG 20 over one hour; no premedication

Primary Outcomes

Measure
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: Through Day 35 after dosing
Pharmacokinetics (Uricase-PEG 20 serum concentration)
time frame: Through Day 35 after dosing
Pharmacodynamics (plasma uric acid concentration)
time frame: Through Day 35 after dosing

Eligibility Criteria

Male or female participants from 40 years up to 75 years old.

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)

Additional Information

Official title A Cohort Dose-Escalation Phase 1 Study of Intravenous Infusion of Uricase-PEG 20
Principal investigator Alan Kivitz, MD
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 intravenous Uricase-PEG 20, the anticipated route of administration to be used in future clinical development in tumor lysis syndrome.
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by EnzymeRx.