This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid levels. This will be followed, in separate subjects, by evaluation of the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous dose of SEL-212, SEL-037 (pegsiticase) plus SEL-110, 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 and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from forming.
This Study will first evaluate the safety and pharmacokinetics of a single intravenous dose of SEL-110, a nanoparticle containing rapamycin, in subjects with elevated blood uric acid levels. This will be followed, in separate subjects, by evaluation of the safety, pharmacokinetics, pharmacodynamics and immunogenicity of a single intravenous dose of SEL-212, SEL-037 (pegsiticase) plus SEL-110, 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 and SEL-110 is designed to prevent unwanted anti-drug-antibodies (ADAs) from forming. Cohorts of subjects in the SEL-110 only arms of the study will be given a single, ascending intravenous dose of SEL-110 and then monitored for safety and rapamycin levels (pharmacokinetics) over 30 days. Cohorts of subjects in the SEL-212 arms of the study will be given a single, ascending intravenous dose of SEL-110 with a fixed dose of SEL-037 and then monitored for safety, rapamycin levels, SEL-037 levels, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days. One additional control group with receive a single intravenous infusion of SEL-037 at a fixed dose and then monitored for safety, SEL-037 levels, uric acid levels and anti-drug-antibodies (ADAs) to SEL-037 for 30 days
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States
Miami Research Associates
Miami, Florida, United States
Orlando Clinical Research Center, Inc.
Orlando, Florida, United States
SNBL Clinical Pharmacology Center Inc.
Baltimore, Maryland, United States
Davita Clinical Research
Minneapolis, Minnesota, United States
Altoona Center for Clincal Research
Duncansville, Pennsylvania, 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-110, SEL-212 or SEL-037 as assessed by frequency of drug related adverse events, graded by severity
Time frame: 30 days
Pharmacokinetics of SEL-110 (AUC)
Measurement of the pharmacokinetics of SEL-110 over 30 days by area under the blood concentration versus time curve (AUC)
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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