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Safety and Efficacy Study of Intramuscular Uricase-PEG 20

NCT ID: NCT01038947

Last Updated: 2009-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Gout Hyperuricemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Uricase-PEG 20

Cohorts will receive ascending doses of Uricase-PEG 20 in a sequential manner. The study will enroll both single dose cohorts and multi-dose cohorts.

Group Type EXPERIMENTAL

Uricase-PEG 20

Intervention Type BIOLOGICAL

Intramuscular injection of Uricase-PEG 20 without premedication

Interventions

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Uricase-PEG 20

Intramuscular injection of Uricase-PEG 20 without premedication

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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EnzymeRx

INDUSTRY

Sponsor Role lead

Responsible Party

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EnzymeRx, LLC

Principal Investigators

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Anthony S Fiorino, MD, PhD

Role: STUDY_DIRECTOR

EnzymeRx, LLC

Patricia Pardo, MD

Role: PRINCIPAL_INVESTIGATOR

MRA Clinical Research

Locations

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MRA Clinical Research

Miami, Florida, United States

Site Status RECRUITING

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Rocelle Flores

Role: CONTACT

Phone: 201-843-4424

Email: [email protected]

Facility Contacts

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Vivian Rosales

Role: primary

Ellen Kivitz

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 12233890 (View on PubMed)

Other Identifiers

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ENZ-102

Identifier Type: -

Identifier Source: org_study_id