A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia

• ABP-671 (Drug): ABP-671 Tablet
• Placebo (Drug): Placebo

Primary outcomes

• Mean percentage change in serum uric acid (sUA) levels [Baseline to the end of the 4-week Dose Evaluation Period]

Secondary outcomes

• Change in mean sUA [Baseline to the end of the 4-week Dose Evaluation Period]
• Mean percentage change and change in mean sUA between cohorts [Baseline to the end of the 4-week Dose Evaluation Period]
• Percentage of patients achieving sUA of < 6.0 mg/dL (0.357 mmol/L), < 5.0 mg/dL (0.297 mmol/L), and < 4.0 mg/dL (0.238 mmol/L) [Baseline to the end of the 4-week Dose Evaluation Period]
• Change in mean sUA compared between BID and QD dosing [Baseline to the end of the 4-week Dose Evaluation Period]

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

* Subject is able to understand the study procedures, the risks involved and willing to provide written informed consent before the first study related activity.
* Subject meets the diagnosis of gout as per the American College of Rheumatism/ European League Against Rheumatism (EULAR) Gout Classification Criteria or diagnosis of hyperuricemia.
* Subject has an sUA level ≥ 7.0 mg/dL at baseline.
* Subject must be willing to discontinue any other UA-lowering medication (e.g., allopurinol, febuxostat, and probenecid) and take gout prophylaxis medication during the study.
* Body mass index (BMI) ≤ 40 kg/m2.

Exclusion Criteria:

* Subject with a documented history of rheumatoid arthritis or other autoimmune disease.
* Subject with any clinically significant hepatic, cardiovascular, renal, neoplastic, psychiatric illness, or hematological disorders such as polycythemia vera, sickle cell disease, or myelodysplastic disorder.
* Subject with a history of alcohol or drug abuse within the past 1 year prior to screening, or current evidence of substance dependence or abuse.
* Subject with a positive test for active hepatitis B, hepatitis C infection or human immunodeficiency virus (HIV) infection.
* Subject with active liver disease, or hepatic dysfunction.
* Subject with an inadequate renal function with estimated serum creatinine > 1.5 mg/dL (> 0.133 mmol/L) or creatinine clearance < 60 mL/min (by Cockcroft-Gault formula).
* Subject with a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia or treated in situ Grade 1 cervical cancer.
* Subject with unstable angina, New York Heart Association class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis within the last 12 months; or subjects currently receiving anticoagulants.
* Subject with QT interval corrected for heart rate according to Fridericia's formula > 470 msec (females) and > 450 msec (males) during the Screening Period, confirmed by a repeat assessment.
* Subject with uncontrolled hypertension
* Subject receiving chronic treatment with more than 325 mg aspirin per day.
* Subject that requires or may require systemic immunosuppressive or immunomodulatory treatment.
* Subject who received any investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to screening.
* Subject who is pregnant or breastfeeding.