Recruiting
Phase 1

ABP-671 with Allopurinol

Sponsor:

Atom Therapeutics Co., Ltd

Code:

NCT07367971

Conditions

Gout Chronic

Gout

DDI (Drug-Drug Interaction)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ABP-671 plus allopurinol

Study Details

Brief summary:

This is a open-Label, Within-Subject Drug-Drug Interaction Study of ABP-671 Added to Stable Allopurinol Therapy in Gout Patients. Pharmacokinetic (PK) interaction between ABP-671 and Allopurinol will be evaluated in participants who are on stable Allopurinol therapy.

Conditions

Gout Chronic

Gout

DDI (Drug-Drug Interaction)

Study ID

NCT07367971

Start date

Jan 23, 2026

Status verified date

Apr, 2026

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Jul 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adults 18-75 years with clinical diagnosis of gout.
  • Stable Allopurinol therapy QD for ≥14 days prior to Day 1.
  • Cohort N: Normal renal function.
  • Cohort R: Moderate renal impairment.

Exclusion Criteria:

  • Clinically significant hepatic impairment.
  • History of Allopurinol hypersensitivity.
  • Pregnancy or breastfeeding.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ABP-671

Interventions

ABP-671 plus allopurinol

All subjects undergo three sequential 7-day periods:

Period 1 (Day 1-7): Allopurinol；

Period 2 (Day 1-7): Allopurinol Plus ABP-671；

Period 3 (Day 1-7): ABP-671；

Primary outcome measure

  • Maximum plasma concentration (Cmax) of allopurinol [ Time Frame: Base line, through Day1, Day 7,Day8,D14,D15,D21 ]
  • Area under the plasma concentration-time curve over the dosing interval (AUC) of allopurinol [ Time Frame: Base line, through Day1, Day 7,Day8,D14,D15,D21 ]

Central Contacts and Locations

Central contacts

MaoE Sun

13914017855mao.e.sun@atombp.com

Locations

Wakefield Clinical Research

Recruiting

Cary, North Carolina, United States, 27560

Principal Investigator:

Xiaohuan Li, MD

More Information

Sponsor

Atom Therapeutics Co., Ltd

Last update posted

Apr 14, 2026

Last verified

Apr, 2026

Keywords

  • gout
  • Gout Chronic
  • ABP-671

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Atom Therapeutics Co., Ltd on 2026-04-14.