Safety and Efficacy Study of Intramuscular Uricase-PEG 20

Gout Clinical Trial

Official title:

A Cohort Dose-Escalation Phase 1 Study of Intramuscular Injection of Uricase-PEG 20

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01038947
• Other study ID #: ENZ-102
• Status: Recruiting
• Phase: Phase 1
• First received: December 22, 2009
• Last updated: December 22, 2009
• Start date: December 2009
• Est. completion date: May 2010

Study information

• Verified date: December 2009
• Source: EnzymeRx
• Contact: Rocelle Flores
• Phone: 201-843-4424
• Email: rflores[@]enzymerx.com
• 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 and multiple intramuscular 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 intramuscular Uricase-PEG 20, the anticipated route of administration to be used in future clinical development in gout.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: May 2010
• Est. primary completion date: April 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
Intramuscular injection of Uricase-PEG 20 without 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)		Up to 35 days after dosing	Yes
Secondary	Pharmacokinetics (Uricase-PEG 20 serum concentration)		Up to 35 days after dosing	No
Secondary	Pharmacodynamics (plasma uric acid concentration)		Up to 35 days after dosing	No
Secondary	Immunogenicity		Up to 35 days after dosing	No