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Monoclonal Antibodies

ABP-745 for Gout (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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to day 14

Awards & highlights

ABP-745 Trial Summary

This trial will test a new drug called ABP-745 in healthy volunteers to see how safe it is, how well it is tolerated, and how the body processes it at different doses.

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.Check my eligibility

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).See study design

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.

ABP-745 Trial 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.

ABP-745 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to day 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to day 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of treatment-emergent adverse events (Safety and Tolerability)

Secondary outcome measures

Plasma pharmacokinetic parameters including peak plasma concentration (Cmax)

Urine pharmacokinetic parameters including amount excreted in urine over the sampling interval (Ae)

ABP-745 Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ABP-745Active Control1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 1Eligibility criteria met

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.Lead Sponsor

6 Previous Clinical Trials

1,291 Total Patients Enrolled

6 Trials studying Gout

1,291 Patients Enrolled for Gout

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to take part in this clinical trial?

"Candidates aged between 18 and 55 years with a confirmed diagnosis of gout are eligible for participation in this trial, which aims to enroll a total of 126 participants."

Answered by AI

What are the potential risks associated with ABP-745 when administered to individuals?

"The safety rating of ABP-745 by our team at Power is 1, as it is a Phase 1 trial with minimal available data to support both its safety and efficacy."

Answered by AI

Are participants currently being recruited for this study?

"According to information available on clinicaltrials.gov, recruitment is underway for this trial. The study was first listed on 1/3/2024 and last modified on 2/5/2024."

Answered by AI

How large is the participant pool for this clinical trial in its entirety?

"Yes, records from clinicaltrials.gov show that this particular study is actively seeking volunteers. The trial was originally listed on January 3rd, 2024 and last updated on February 5th, 2024. There are spots for enrollment of up to 126 participants at a single site."

Answered by AI