ABP-671 for Gout

MS
Overseen ByMaoE Sun
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Atom Therapeutics Co., Ltd
Must be taking: Allopurinol
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with gout who have been taking allopurinol daily for at least 14 days. Participants are divided into two groups based on kidney function: one with normal and another with moderate impairment.

Inclusion Criteria

I am between 18 and 75 years old and have been diagnosed with gout.
I have been taking Allopurinol daily for at least 14 days.
My kidney function is normal.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ABP-671 in combination with stable Allopurinol therapy to evaluate pharmacokinetic interactions

3 weeks
Visits on Day 1, Day 7, Day 8, Day 14, Day 15, Day 21

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ABP-671

Trial Overview

The study tests how ABP-671 interacts with allopurinol in patients already using allopurinol for gout. It's an open-label trial, meaning everyone knows which drugs are given, and it measures the drug levels in the body.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: ABP-671Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Atom Therapeutics Co., Ltd

Lead Sponsor