A Study to Evaluate the Safety, Tolerability, PK, and PD Properties of PRX-115 in Adult Volunteers With Elevated Uric Acid Levels

Participants will be assigned to 1 of 8 sequential dosing cohorts, each composed of 8 participants (6 active + 2 placebo) who will receive a single dose of PRX-115 or placebo by intravenous (IV) infusion.

Inclusion criteria

• Males or females 18 to 65 years of age, inclusive.
• Serum uric acid greater than 6.0 mg/dL (0.35 mmol/L) at the Screening visit.
• Body mass index within the range 18.5 to 40 kg/m^2, inclusive, at the Screening visit.
• Women of childbearing potential may be included only if they have a negative beta human chorionic gonadotropin (β-hCG) test result at Screening.
• Men and women of childbearing potential and their partners should use double barrier contraception.

Exclusion criteria

• Has any condition known to have arthritis as a clinical manifestation
• Had greater than or equal to 1 gout flare in the last year prior to either Screening or Day -1.
• Has clinical evidence of subcutaneous tophi at either Screening or Day -1.
• Estimated glomerular filtration rate (eGFR) value less than or equal to 60 mL/min/1.73m^2
• History of significant renal disease, and/or presence of renal stones at either Screening or Day -1.
• Has a history of anaphylaxis, severe allergic reactions, or severe atopy.
• History of autoimmune disorders, and/or participant is immunocompromised or treated with immunosuppressive medications.
• Has evidence of cardiovascular or cerebrovascular disease.
• History of congestive heart failure, New York Heart Association Class III or IV.
• BP outside the range of 90 to 150 mm Hg for systolic or 50 to 95 mm Hg for diastolic.
• Participants with hypertension who are not on stable medication for at least 6 months.
• Has uncontrolled type 2 diabetes
• Concurrent treatment with urate lowering drugs (ULDs).
• Prior exposure to any experimental or marketed uricase (eg, rasburicase [Elitek, Fasturtec], pegloticase [Krystexxa®], pegadricase [SEL-212]).
• Glucose-6-phosphate dehydrogenase (G6PD) deficiency or known catalase deficiency.