Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease

Inclusion Criteria: * Male or female, age 18 to 70 years * Serum UA level ≥ 8.0 mg/dL at Screening (hyperuricemia) * Meets 2015 American College of Rheumatology (ACR)/EULAR criteria for gout * Screening eGFR of ≥60 - \<90 mL/minute/1.73 m2 for Cohort A and ≥30 - \<60 mL/minute/1.73 m2 for Cohort B. * Concomitant medications stable for a minimum of 4 weeks prior to and during Screening * Body Mass Index (BMI) ≥ 18 and ≤ 40 kg/m2, inclusive, at screening * Not pregnant, not capable of pregnancy, not nursing, and agrees to use an effective method of contraception; males subjects must agree to abstain from sperm donation Exclusion Criteria: * Currently taking any oral urate-lowering medication within 2 weeks prior to Screening * Prior uricase therapy or exposure to recombinant uricase, such as Rasburicase or Pegloticase * Gout flare requiring treatment within 14 days prior to or during Screening * Clinically significant finding during Screening, any ongoing clinically significant illness requiring a clinically significant intervention or change in management within 4 weeks prior to or during Screening * History of GI surgery, including gastric sleeve, Roux-en-Y or gastric banding (unless gastric band removed for a minimum of 12 months prior to Screening * Received treatment with or exposure to an Investigational drug or device within 30 days - prior to or during Screening * Prior dosing in ALLN-346 clinical study * Per Investigator judgment, is not an ideal clinical study candidate