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

NCT04638543 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-04-12

No results posted yet for this study

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.

Conditions

  • Gout
  • Hyperuricemia

Interventions

DRUG

ABP-671

ABP-671 Tablet

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Atom Therapeutics Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04638543 on ClinicalTrials.gov