An Inpatient Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects (Study 201)

The purpose of this Phase IIa study is to evaluate the safety and tolerability of ALLN-346 in subjects with hyperuricemia in an inpatient, controlled setting.

This is a Phase II, 7-day, randomized, double-blind, placebo-controlled study of orally administered ALLN-346 in subjects with hyperuricemia, with subpopulations to include generally healthy hyperuricemic subjects with normal kidney function and those with mild to moderate chronic kidney disease (CKD). Study will take place at a clinical pharmacology unit (CPU). The study will have two Parts. Part 1 will include subjects with serum urate ≥ 6.8 mg/dL and eGFR ≥ 60 mL/minute/1.73 m2 (subjects with eGFR of stage 2 CKD and with normal kidney function). Part 2 will include subjects with serum urate ≥ 6.8 mg/dL and eGFR 45-100 mL/minute/1.73 m2 (eGFR of CKD Stages 2- 3a). The study will evaluate safety, tolerability, pharmacokinetics (lack of absorption) and pharmacodynamics of ALLN-346.