Safety and Efficacy Study of Intravenous Uricase-PEG 20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Study Completion Date

2010-03-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Gout Hyperuricemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Uricase-PEG 20

Cohorts will receive ascending doses of Uricase-PEG 20 in a sequential manner

Group Type EXPERIMENTAL

Uricase-PEG 20

Intervention Type BIOLOGICAL

Intravenous infusion of Uricase-PEG 20 over one hour; no premedication

Interventions

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Uricase-PEG 20

Intravenous infusion of Uricase-PEG 20 over one hour; no premedication

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes