Safety and Efficacy Study of Intravenous Uricase-PEG 20

Status unconfirmed · Phase 1

Conditions studied: Gout, Hyperuricemia

In brief

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

Key facts

Study ID

NCT01021241

Run by

EnzymeRx

People needed

20

Starts

2009-10-01

Expected to finish

2010-03-01

Last updated by the study team

2010-02-23

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• MRA Clinical Research — Miami, Florida, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States

Full record on ClinicalTrials.gov

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