Safety and Efficacy Study of Intravenous Uricase-PEG 20 - Full Text View

Sponsor:	EnzymeRx
Information provided by:	EnzymeRx
ClinicalTrials.gov Identifier:	NCT01021241

Purpose

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

Condition	Intervention	Phase
Gout Hyperuricemia	Biological: Uricase-PEG 20	Phase I

Study Type:	Interventional
Study Design:	Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Cohort Dose-Escalation Phase 1 Study of Intravenous Infusion of Uricase-PEG 20

Resource links provided by NLM:

MedlinePlus related topics: Gout

U.S. FDA Resources

Further study details as provided by EnzymeRx:

Primary Outcome Measures:

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) [ Time Frame: Through Day 35 after dosing ] [ Designated as safety issue: Yes ]
Pharmacokinetics (Uricase-PEG 20 serum concentration) [ Time Frame: Through Day 35 after dosing ] [ Designated as safety issue: No ]
Pharmacodynamics (plasma uric acid concentration) [ Time Frame: Through Day 35 after dosing ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	October 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Uricase-PEG 20 Cohorts will receive ascending doses of Uricase-PEG 20 in a sequential manner	Biological: Uricase-PEG 20 Intravenous infusion of Uricase-PEG 20 over one hour; no premedication

Detailed 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.

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01021241

Locations

United States, Florida
MRA Clinical Research
Miami, Florida, United States, 33143
United States, Pennsylvania
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States, 16635

Sponsors and Collaborators

EnzymeRx

Investigators

Study Director:	Anthony S Fiorino, MD, PhD	EnzymeRx, LLC
Principal Investigator:	Alan Kivitz, MD	Altoona Center for Clinical Research

More Information

Additional Information:

Homepage of sponsoring company This link exits the ClinicalTrials.gov site

Abstract describing animal pharmacokinetic studies This link exits the ClinicalTrials.gov site

Publications:

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.

Responsible Party:	Anthony Fiorino, MD, PhD, EnzymeRx, LLC
ClinicalTrials.gov Identifier:	NCT01021241 History of Changes
Other Study ID Numbers:	ENZ-101
Study First Received:	November 24, 2009
Last Updated:	February 22, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hyperuricemia
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012