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Safety and Efficacy Study of Intravenous Uricase-PEG 20

NCT01021241 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-02-23

No results posted yet for this study

Summary

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

Conditions

  • Gout
  • Hyperuricemia

Interventions

BIOLOGICAL

Uricase-PEG 20

Intravenous infusion of Uricase-PEG 20 over one hour; no premedication

Sponsors & Collaborators

  • EnzymeRx

    lead INDUSTRY

Principal Investigators

  • Anthony S Fiorino, MD, PhD · EnzymeRx, LLC

  • Alan Kivitz, MD · Altoona Center for Clinical Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-03-31
Completion
2010-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01021241 on ClinicalTrials.gov