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A Cohort Dose-Escalation Phase 1 Study of Intramuscular Injection of Uricase-PEG 20
The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single and multiple intramuscular doses of Uricase-PEG 20
Details
| Lead sponsor | EnzymeRx |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 28 |
| Start date | 2009-12 |
| Completion | 2010-05 |
Conditions
- Gout
- Hyperuricemia
Interventions
- Uricase-PEG 20
Primary outcomes
- 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
Countries
United States