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NCT04060173
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671
Phase 1 trial testing ABP-671 in Hyperuricemia in 27 participants. Completed in 7 February 2020.
29 December 2019
Quick facts
| Lead sponsor | Atom Therapeutics Co., Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 5 September 2019 |
| Primary completion | 29 December 2019 |
| Estimated completion | 7 February 2020 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ABP-671 — full drug profile →
- Placebo
Conditions studied
- Hyperuricemia — all drugs for Hyperuricemia →
- Gout — all drugs for Gout →
Sponsor
Atom Therapeutics Co., Ltd — full company profile →
Who can join
Adults 18 to 65, any sex, with Hyperuricemia or Gout. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of ABP-671 administered orally in subjects with hyperuricemia.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Review of Urate-Lowering Therapeutics: From the Past to the Future.
Jenkins C, Hwang JH, Kopp JB, Winkler CA, et al · · 2022 · cited 38× · PMID 36081938 · DOI 10.3389/fphar.2022.925219 -
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effects of Single and Multiple Oral Doses of ABP-671 in Healthy and Hyperuricemic Subjects.
Gurwith M, Wu RJ, Schwertschlag U, Jin AW, et al · · 2025 · PMID 41340907 · DOI 10.2147/dddt.s553918
Verify or expand the search:
- PubMed search for NCT04060173
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of ABP-671
Trials testing the same drug.
- NCT06276556 — Extension Study of ABP-671 in Participants With Gout · Phase 2, PHASE3 · terminated
- NCT05818085 — Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout · Phase 2, PHASE3 · completed
- NCT04638543 — A Study to Assess the Efficacy, Safety, and Pharmacokinetics of ABP-671 in Patients With Gout or Hyperuricemia · Phase 2 · completed
- NCT04303039 — Study to Investigate the Effects of Food on Relative Bioavailability of ABP-671 Tablets in Healthy Subjects · Phase 1 · completed
- NCT03906006 — A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ABP-671 in Healthy Subjects · Phase 1 · completed
Other recruiting trials for Hyperuricemia
Currently open trials in the same condition.
- NCT07144332 — This Study is to Estimate the Efficacy of Hemodialysis Alone for Uric Acid Clearance in Patients on Hemodialysis. In Ord · recruiting
- NCT07400549 — Prospective Exploratory Study on the Comprehensive Application Effectiveness of Exercise Prescription Decision Support T · NA · recruiting
- NCT06859073 — A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia · Phase 1 · recruiting
- NCT06463561 — CPAP Effect on Lipid Profile and Hyperuricemia in Patients With Dyslipidemia and Moderate-severe Obstructive Sleep Apnea · Phase 4 · recruiting
- NCT06729853 — PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function · Phase 1, PHASE2 · active not recruiting
Other Atom Therapeutics Co., Ltd trials
Trials by the same sponsor.
- NCT07323095 — Evaluate the Efficacy and Safety of ABP-671 in Subjects With Chronic Kidney Disease and Hyperuricaemia · Phase 2 · not yet recruiting
- NCT07367971 — Drug-Drug Interaction Study of ABP-671 in Gout Patients · Phase 1 · recruiting
- NCT06276556 — Extension Study of ABP-671 in Participants With Gout · Phase 2, PHASE3 · terminated
- NCT06258213 — A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral ABP-745 Administration in Healthy Volunteers · Phase 1 · completed
- NCT05818085 — Phase 2b/3 Study to Assess ABP-671 a Novel URAT1 Inhibitor in Participants With Gout · Phase 2, PHASE3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04060173 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Atom Therapeutics Co., Ltd
- Last refreshed: 12 February 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04060173.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing