This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy, safety, and pharmacokinetics study of 6 different dose regimens of ABP-671 compared with placebo. The study will consist of three sequential groups with escalating total daily ABP-671 doses. Each group is further divided into two dose cohorts with either QD or BID dosing. Each dose group will have 3 stages following screening: Run-in, Dose Evaluation, and Follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Paratus - Canberra Clinic
Canberra, Australia
Paratus - Central Coast Clinic
Kanwal, Australia
Peninsula Private Hospital
Kippa-Ring, Australia
Emeritus Research - Melbourne
Melbourne, Australia
Paratus - Western Sydney Clinic
Mean percentage change in serum uric acid (sUA) levels
Time frame: Baseline to the end of the 4-week Dose Evaluation Period
Change in mean sUA
Time frame: Baseline to the end of the 4-week Dose Evaluation Period
Mean percentage change and change in mean sUA between cohorts
Time frame: 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)
Time frame: Baseline to the end of the 4-week Dose Evaluation Period
Change in mean sUA compared between BID and QD dosing
Time frame: Baseline to the end of the 4-week Dose Evaluation Period
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Sydney, Australia