Safety and Efficacy Study of Intramuscular Uricase-PEG 20

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by EnzymeRx.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
EnzymeRx
ClinicalTrials.gov Identifier:
NCT01038947
First received: December 22, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

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


Condition Intervention Phase
Gout
Hyperuricemia
Biological: Uricase-PEG 20
Phase 1

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 Intramuscular Injection of Uricase-PEG 20

Resource links provided by NLM:


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: Up to 35 days after dosing ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics (Uricase-PEG 20 serum concentration) [ Time Frame: Up to 35 days after dosing ] [ Designated as safety issue: No ]
  • Pharmacodynamics (plasma uric acid concentration) [ Time Frame: Up to 35 days after dosing ] [ Designated as safety issue: No ]
  • Immunogenicity [ Time Frame: Up to 35 days after dosing ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: December 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: April 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. The study will enroll both single dose cohorts and multi-dose cohorts.
Biological: Uricase-PEG 20
Intramuscular injection of Uricase-PEG 20 without 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 intramuscular Uricase-PEG 20, the anticipated route of administration to be used in future clinical development in gout.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01038947

Contacts
Contact: Rocelle Flores 201-843-4424 ext 203 rflores@enzymerx.com

Locations
United States, Florida
MRA Clinical Research Recruiting
Miami, Florida, United States, 33143
Contact: Vivian Rosales    305-772-2857    vrosales@miamiresearch.com   
Principal Investigator: Patricia Pardo, MD         
United States, Pennsylvania
Altoona Center for Clinical Research Recruiting
Duncansville, Pennsylvania, United States, 16635
Contact: Ellen Kivitz    814-693-0300 ext 224      
Principal Investigator: Alan J Kivitz, MD         
Sponsors and Collaborators
EnzymeRx
Investigators
Study Director: Anthony S Fiorino, MD, PhD EnzymeRx, LLC
Principal Investigator: Patricia Pardo, MD MRA Clinical Research
  More Information

Additional Information:
Publications:
Responsible Party: Anthony Fiorino, MD, PhD, EnzymeRx, LLC
ClinicalTrials.gov Identifier: NCT01038947     History of Changes
Other Study ID Numbers: ENZ-102
Study First Received: December 22, 2009
Last Updated: December 22, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hyperuricemia
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014