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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Intravenous infusion of SEL-037
Altoona Center for Clincal Research
Duncansville, Pennsylvania, United States
Metroplex Clinical Research Center
Dallas, Texas, United States
Safety and tolerability as assessed by frequency of drug related adverse events, graded by severity
To assess the safety and tolerability of a single infusion of SEL-037 as assessed by frequency of drug related adverse events, graded by severity
Time frame: 30 days
Pharmacokinetics of SEL-037 (AUC)
Measurement of the pharmacokinetics of SEL-037 over 30 days by area under the serum concentration versus time curve (AUC)
Time frame: 30 days
Pharmacodynamics of SEL-037 (blood uric acid levels)
Pharmacodynamics of SEL-037 by measurement of blood uric acid levels over 30 days
Time frame: 30 days
Immunogenicity of SEL-037 (measurement of anti-drug antibody levels)
Immunogenicity of SEL-037 by measurement of anti-drug antibody levels over 30 days
Time frame: 30 days
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