drugset / Trial / NCT04638543

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

NCT04638543

Phase 2 Completed 60 enrolled Atom Therapeutics Co., Ltd
RandomizedSequentialQuadruple-blindTreatment

Summary

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.

Timeline

Start
2020-11-27
Primary completion
2021-10-26
Completion
2021-10-26

Drugs

EvaluationDrugModalityDoseRoute
Subject ABP-671 Unknown

Indications