NCT01038947|UnknownPhase 1
Safety and Efficacy Study of Intramuscular Uricase-PEG 20
A Cohort Dose-Escalation Phase 1 Study of Intramuscular Injection of Uricase-PEG 20
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A Cohort Dose-Escalation Phase 1 Study of Intramuscular Injection of Uricase-PEG 20
Sponsor study identifier
interventional
28
1 country
2
Study Start
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single and multiple intramuscular doses of Uricase-PEG 20
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
December 22, 2009
Actual (reported)December 24, 2009
Actual (reported)April 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Pharmacokinetics (Uricase-PEG 20 serum concentration)
Up to 35 days after dosing
Pharmacodynamics (plasma uric acid concentration)
Up to 35 days after dosing
Immunogenicity
Up to 35 days after dosing
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.
Intramuscular injection of Uricase-PEG 20 without premedication
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
MRA Clinical Research
Miami, Florida, 33143, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635, United States
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.
Anthony S Fiorino, MD, PhD
EnzymeRx, LLC
Patricia Pardo, MD
MRA Clinical Research
First Submitted
December 22, 2009
First Posted
December 24, 2009
Study Start
December 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2010
Estimated (date passed)The Effect of Naproxen on the Pharmacokinetic Profile of LC350189 in Healthy Adults
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2010
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 24, 2009
Record last verified: 2009-12
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Source: ClinicalTrials.gov.
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