Gout ChronicPhase 1NCT07367971
Drug-Drug Interaction Study of ABP-671 in Gout Patients
A Phase 1 study testing ABP-671 plus allopurinol in people with Gout Chronic and Gout, run by Atom Therapeutics Co., Ltd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gout Chronic, Gout, DDI (Drug-Drug Interaction)
- What is being tested?
- ABP-671 plus allopurinol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2026to 31 Aug 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Clinically significant hepatic impairment.
- History of Allopurinol hypersensitivity.
- Pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wakefield Clinical Research
Cary, North Carolina, 27560
Xiaohuan Li, MD
About this study
Official title: Open-Label, Within-Subject Drug-Drug Interaction Study of ABP-671 Added to Stable Allopurinol Therapy in Gout Patients
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)
- Being tested
- ABP-671 plus allopurinol
- Keywords
- gout, Gout Chronic, ABP-671
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABP-671 plus allopurinolDrug
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；
| Study group | Role | What they receive |
|---|---|---|
| ABP-671 | Experimental | Not described Receives: Drug: ABP-671 plus allopurinol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum plasma concentration (Cmax) of allopurinol
Maximum observed plasma concentration (Cmax) of allopurinol following administration of allopurinol alone and in combination with ABP-671 at steady state.
Measured: Base line, through Day1, Day 7,Day8,D14,D15,D21
Area under the plasma concentration-time curve over the dosing interval (AUC) of allopurinol
Area under the plasma concentration-time curve over the dosing interval (AUC) of allopurinol following administration of allopurinol alone and in combination with ABP-671 at steady state.
Measured: Base line, through Day1, Day 7,Day8,D14,D15,D21
Secondary outcomes (3)
Maximum plasma concentration (Cmax) of ABP-671
Maximum observed plasma concentration (Cmax) of ABP-671 when administered with allopurinol and following a post-combination ABP-671 alone period.
Measured: Though Day7,Day8,Day14,Day15,Day21
Area under the plasma concentration-time curve over the dosing interval (AUC) of ABP-671
Area under the plasma concentration-time curve over the dosing interval (AUC) of ABP-671 when administered with allopurinol and following a post-combination ABP-671 alone period.
Measured: Though Day7,Day8,Day14,Day15,Day21
Incidence of treatment-emergent adverse events (TEAEs)
Number and percentage of participants experiencing treatment-emergent adverse events.
Measured: Through study completion, an average of 51 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start23 Jan 2026
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atom Therapeutics Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367971
- Sponsor's protocol ID
- ABP-671-DDI-01
- Status last verified
- Apr 2026
- First submitted
- 27 Dec 2025
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: there is no need at present.
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Within-Subject Drug-Drug Interaction Study of ABP-671 Added to Stable Allopurinol Therapy in Gout Patients
- ClinicalTrials.gov ID
- NCT07367971
- Acronym / sponsor ID
- ABP-671-DDI-01
- Conditions
- Gout Chronic, Gout, DDI (Drug-Drug Interaction)
- Keywords
- gout, Gout Chronic, ABP-671
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Atom Therapeutics Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2026 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABP-671 | Experimental | Drug: ABP-671 plus allopurinol |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Clinically significant hepatic impairment.
- History of Allopurinol hypersensitivity.
- Pregnancy or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABP-671 plus allopurinolAll 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； | Drug | ABP-671 |
Primary outcome
Maximum plasma concentration (Cmax) of allopurinol
Time frame: Base line, through Day1, Day 7,Day8,D14,D15,D21
Maximum observed plasma concentration (Cmax) of allopurinol following administration of allopurinol alone and in combination with ABP-671 at steady state.
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
Area under the plasma concentration-time curve over the dosing interval (AUC) of allopurinol following administration of allopurinol alone and in combination with ABP-671 at steady state.
3 secondary outcomes
Maximum plasma concentration (Cmax) of ABP-671
Time frame: Though Day7,Day8,Day14,Day15,Day21
Area under the plasma concentration-time curve over the dosing interval (AUC) of ABP-671
Time frame: Though Day7,Day8,Day14,Day15,Day21
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Through study completion, an average of 51 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Individual participant dataSharing planned: No. there is no need at present.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABP-671 plus allopurinol in people with Gout Chronic and Gout, run by Atom Therapeutics Co., Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact MaoE Sun (13914017855, mao.e.sun@atombp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum plasma concentration (Cmax) of allopurinol (time frame: Base line, through Day1, Day 7,Day8,D14,D15,D21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.