Gout Clinical Trial
Official title:
An Open-Label, Sequential, Ascending Single-Dose Safety, Tolerability, Pharmacokinetic and Pharmacodynamics Study of an Intravenous Infusion of SEL-037 in Subjects With Elevated Blood Uric Acid Levels
This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted.
This Study will evaluate the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous infusion of SEL-037 (pegsiticase), a pegylated uricase, in subjects with elevated blood uric acid levels. Uricase is an enzyme that converts uric acid to the readily soluble allantoin that is then excreted. Cohorts of Subjects will be given a single, ascending dose intravenous infusion of SEL-037 and then monitored for safety, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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