Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001.

Main Inclusion Criteria:

1. Male or female, ≥18 and ≤75 years of age, willing and able to provide informedconsent and to adhere to the requirements and guidelines of the protocol.

2. Body mass index ≥19 and ≤40 kg/m2 at the Screening Visit (Visit 1).

3. Already have been diagnosed with gout according to the current American College ofRheumatology (ACR) scoring criteria for the classification of primary gout; or hassymptoms of gout with at least 1 of the following: i. 3 gout flares in the previous 18 months prior to screening; or ii. Presence of at least 1 gout tophus; or iii.Current diagnosis of gouty arthritis; Subject must be refractory to SoC XOI therapy,or in whom XOI is contraindicated. Refractory to SOC XOI is defined by a medicalhistory of failure to normalize sUA to <6 mg/dL (the ACR target for gout) with atleast 3 months of SoC XOI treatment at the maximum medically appropriate dose. XOIcontraindication can be self-reported medical contraindication to SoC XOI therapy orin whom SoC XOI therapy is not considered medically appropriate treatment forsymptomatic gout. Subject can still participate in the clinical trial if SOC XOItherapy is considered medically not appropriate or contraindicated.

4. Subject must have been on SoC XOI therapy for gout and hyperuricemia for at least 4weeks immediately before the Randomization Visit (Day 1, Visit 4) unless SoC XOItherapy is contraindicated or not medically appropriate. Subjects who stopped SoCXOI therapy within 4 weeks of the Screening Visit are eligible for the study butmust be restarted on SoC XOI therapy and confirmed resistant to XOI therapy (sUAlevels ≥7.0 mg/dL) after at least 4 weeks of treatment.

5. Subject must have sUA levels ≥7.0 mg/dL by central laboratory results at theScreening Visit (Visit 1) and prior to randomization at the Randomization Visit (Day 1, Visit 4).

Main Exclusion Criteria:

1. Subjects not previously diagnosed as having gout before the Screening Visit.

2. Female subject is pregnant, planning to get pregnant, lactating/breastfeeding, orhas a positive urine pregnancy test at the Screening Visit or prior to randomizationat the Randomization Visit (Day 1, Visit 4).

3. Subject has used any prescription drugs (eg, losartan, pegloticase, URAT1inhibitors), OTC medications, herbal medications or products, vitamins, or mineralsthat are known to lower sUA levels (except SoC XOI therapies) within 14 days priorto the Randomization Visit (Day 1, Visit 4). Exceptions may be made on acase-by-case basis (such as chronic use of low dose aspirin) following discussionand agreement between the investigator and sponsor. Subjects who are already takinglosartan for blood-pressure control are allowed to enroll in the study and continuetaking losartan if they have been on a stable dose for at least 6 months.

4. Subject was not compliant with taking placebo during the Run-in Period (defined astaking <80% or >120% of planned placebo doses) or the investigator determines thatthe subject was not compliant with SoC XOI gout medications (unless SoC XOI therapyis contraindicated or not medically appropriate) during the Run-in Period asassessed prior to randomization at the Randomization Visit (Day 1, Visit 4).

5. Subject had an acute gout flare (exclusive of symptomology associated with chronicsynovitis/arthritis) that did not resolve at least 14 days prior to theRandomization Visit (Day 1, Visit 4). If an acute gout flare occurs during theScreening or Run-in Periods, the subject may be rescreened after a period of atleast 14 days has passed following resolution of the flare.

6. Serum creatinine level >1.5 mg/dL and/or eGFR ≤60 mL/min/1.73 m2 calculated usingthe Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation23 bycentral laboratory results at the Screening Visit (Visit 1) or prior torandomization at the Randomization Visit (Day 1, Visit 4).