 AC-201CR is a control released formulation of AC-201 that in previous clinical studies showed potential dual effects in both reducing serum uric acid sUA and gout flares. The mechanism of actions of AC-201 include the inhibition of the production and activity of caspase-1 and interleukin-1β IL-1β, and selective inhibition of re-absorption transporters in kidney. The goal of gout treatment is to reduce serum uric acid sUA concentrations below the urate solubility limit while avoiding acute gout flares. However, the initiation of urate-lowering therapy ULT increases the occurrence of acute gouty arthritis flares. IL-1β plays a key role in mediating this inflammatory response. The study is designed to test the urate-lowering effect, safety, and tolerability of AC-201CR in an initial dosing period, followed by addition of an ULT to test the efficacy and safety of the combination and prophylaxis of gout flares during ULT. 