Safety and Efficacy Study of Intravenous Uricase-PEG 20

Gout Clinical Trial

Official title:

A Cohort Dose-Escalation Phase 1 Study of Intravenous Infusion of Uricase-PEG 20

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01021241
• Other study ID #: ENZ-101
• Status: Active, not recruiting
• Phase: Phase 1
• First received: November 24, 2009
• Last updated: February 22, 2010
• Start date: October 2009
• Est. completion date: March 2010

Study information

• Verified date: February 2010
• Source: EnzymeRx
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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)

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gout
• Hyperuricemia

Intervention

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

Locations

Country	Name	City	State
United States	Altoona Center for Clinical Research	Duncansville	Pennsylvania
United States	MRA Clinical Research	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
EnzymeRx

Country where clinical trial is conducted

United States, 

References & Publications (1)

Bomalaski JS, Holtsberg FW, Ensor CM, Clark MA. Uricase formulated with polyethylene glycol (uricase-PEG 20): biochemical rationale and preclinical studies. J Rheumatol. 2002 Sep;29(9):1942-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)		Through Day 35 after dosing	Yes
Primary	Pharmacokinetics (Uricase-PEG 20 serum concentration)		Through Day 35 after dosing	No
Primary	Pharmacodynamics (plasma uric acid concentration)		Through Day 35 after dosing	No

External Links

•   Abstract describing animal pharmacokinetic studies