Trials / Completed
CompletedNCT04638543
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia
A Randomized, Double-Blind, Dose-Ranging, Placebo-Controlled, Multicenter, Phase 2a Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 Monotherapy in Patients With Gout or Hyperuricemia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Atom Therapeutics Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABP-671 | ABP-671 Tablet |
| DRUG | Placebo | Placebo |
Timeline
- Start date
- 2020-11-27
- Primary completion
- 2021-10-26
- Completion
- 2021-10-26
- First posted
- 2020-11-20
- Last updated
- 2023-04-12
Locations
5 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT04638543. Inclusion in this directory is not an endorsement.