What side effects are associated with this type of intervention?

Common treatments for gout, such as allopurinol and febuxostat, have been associated with various side effects. Allopurinol can cause skin rashes and, rarely, severe hypersensitivity reactions. Febuxostat has similar side effects, including liver function abnormalities and cardiovascular events. Anakinra, used for acute gout flares, generally shows no unexpected serious adverse events. Dotinurad, a newer treatment, has shown a good safety profile without significant increases in adverse events with dose escalation. Overall, these treatments are generally well-tolerated, but monitoring for specific side effects is recommended.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of gout, including febuxostat and allopurinol, which are urate-lowering therapies. Febuxostat, approved for hyperuricemia in gout patients, has been shown to be effective but carries a boxed warning for increased cardiovascular risk. Allopurinol is another commonly used urate-lowering drug. Additionally, anakinra has been studied for acute gout flares, showing efficacy in reducing pain. These treatments focus on managing uric acid levels and alleviating symptoms, similar to the goals of the ABP-745 study, which evaluates safety, tolerability, and pharmacokinetics.

What other types of research exist?

Promising novel alternatives for gout treatment in 2024 include: 1) New urate-lowering medications such as lesinurad and pegloticase, which can be used alone or in combination with allopurinol. 2) Anti-inflammatory agents targeting IL-1β, such as anakinra and canakinumab, which have shown efficacy in treating acute gout flares. These alternatives offer new options for patients, particularly those with inadequate response to traditional therapies.

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Monoclonal Antibodies

ABP-745 Safety Study in Healthy Volunteers (ABP-745 Trial)

Phase 1

Recruiting

Research Sponsored by Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy male or female volunteers, aged 18 and 55 years at the time of signing the informed consent form (ICF)

Be between 18 and 65 years old

Must not have

Received an experimental agent (vaccine, drug, biologic, device, blood product or medication) within 1 month or 5 times half-life prior to the first dose of IP

Smoking history (≥ 5 cigarettes per day) within 3 months before the screening, or cannot abstain from any tobacco products during the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial will test a new drug called ABP-745 in healthy volunteers. Researchers want to see if the drug is safe and how it moves through the body. They will give different doses to understand its effects better.

Who is the study for?

Healthy volunteers aged 18-55 with a BMI of 18-30 kg/m2 and weight over 50 kg for males and 45 kg for females. Participants must not be on medication, have no history of significant health issues that affect drug processing, no drug abuse in the past two years, non-smokers or able to abstain during the study, and women must use contraception.

What is being tested?

The trial is testing ABP-745's safety and how it's processed by the body when taken orally. It involves giving healthy people either ABP-745 or a placebo without them knowing which one they're getting. The test will happen twice: once as a single dose (Part 1) and again as multiple doses (Part 2).

What are the potential side effects?

Since this is an initial test in humans, specific side effects are unknown but may include typical reactions to oral medications such as stomach upset, headache, dizziness or allergic reactions. Safety monitoring includes physical exams and lab tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 55 years old and in good health.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I haven't taken any experimental treatments within the last month.

Select...

I have smoked at least 5 cigarettes daily in the past 3 months or cannot quit smoking during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ABP-745Active Control1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for gout include xanthine oxidase inhibitors (XOIs) such as allopurinol and febuxostat. These medications work by inhibiting the enzyme xanthine oxidase, which is responsible for converting hypoxanthine to xanthine and then to uric acid. By reducing the production of uric acid, these drugs help to lower serum uric acid levels, thereby preventing the formation of urate crystals that cause gout attacks. This mechanism is crucial for gout patients as it directly addresses the root cause of the disease, reducing the frequency and severity of painful flare-ups. The study of ABP-745, which focuses on safety, tolerability, and pharmacokinetics, is important as it may offer a new therapeutic option with potentially improved outcomes for patients.

Comparison of Febuxostat and Allopurinol in the Treatment of Patients with Chronic Kidney Disease Stage 3∼5 with Hyperuricemia.Uric acid lowering for slowing CKD progression after the CKD-FIX trial: a solved question or still a dilemma?Recent approaches to gout drug discovery: an update.