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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01038947
Other study ID # ENZ-102
Secondary ID
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


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
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