A Cohort Dose-Escalation Phase 1 Study of Intravenous Infusion of Uricase-PEG 20

NCT01021241 Phase 1 UNKNOWN

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

Details

Lead sponsor	EnzymeRx
Phase	Phase 1
Status	UNKNOWN
Enrolment	20
Start date	2009-10
Completion	2010-03

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) — Through Day 35 after dosing
• Pharmacokinetics (Uricase-PEG 20 serum concentration) — Through Day 35 after dosing
• Pharmacodynamics (plasma uric acid concentration) — Through Day 35 after dosing

Countries

United States