ABP-745 Safety Study in Healthy Volunteers

(ABP-745 Trial)

Overseen By Ullrich Schwertschlag, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

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

Must not be taking: All medications

Disqualifiers: Gastrointestinal, Liver, Kidney, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effects of a new treatment called ABP-745 in healthy volunteers. Researchers will examine how the body processes this treatment and how well people tolerate it, comparing it to a placebo (a substance with no active drug). Participants will take either ABP-745 or a placebo in varying doses. Healthy individuals who do not smoke, have no history of certain diseases, and are not taking other medications may be suitable candidates. As a Phase 1 trial, participants have the opportunity to be among the first to receive this new treatment and contribute to understanding its effects in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications (both prescription and nonprescription) at least 14 days before the first dose of the study drug, except for oral contraceptives or topical ointments, which may be allowed.

Is there any evidence suggesting that ABP-745 is likely to be safe for humans?

Research has shown that ABP-745 was well-tolerated in earlier studies with healthy volunteers. These studies found the drug to be safe, with no major safety concerns, and most reported side effects were mild. The drug's action in the body was predictable and dose-dependent, meaning its effects and breakdown matched expectations based on the dosage.

Overall, these findings suggest that ABP-745 is generally safe for healthy individuals, with any side effects likely being minor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ABP-745 because it offers a potentially new approach to treatment with its unique active ingredient or mechanism of action, which is not yet specified in detail. Unlike standard treatments that often rely on well-established pathways, ABP-745 may target a different biological process or provide a novel delivery method that enhances effectiveness or reduces side effects. This innovative angle could lead to improved outcomes or better tolerability for patients, setting it apart from existing options.

What evidence suggests that ABP-745 could be effective?

Research has shown that ABP-745 appears promising as a treatment in early studies. It has been tested for its ability to reduce pain and swelling during sudden gout attacks. Initial findings suggest that ABP-745 is generally safe, with most participants not experiencing serious side effects. The drug also behaves predictably in the body at different doses. While more research is needed, these early results offer hope for its future use in treating gout symptoms. Participants in this trial will receive either ABP-745 or a placebo to further assess its safety in healthy volunteers. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Body mass index (BMI) range within 18 ~ 30 kg/m2, and body weight of ≥ 50.0 kg for male and ≥ 45.0 kg for female

I am generally healthy according to recent medical exams and tests.

I will use effective birth control from screening until 90 days after my last dose.

Exclusion Criteria

Known history of drug abuse within 2 years before the screening; or positive drug abuse test at screening

Blood donation or blood loss of more than 400 mL within 3 months before the screening

Positive screening test for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Dose Treatment

Participants receive a single oral dose of ABP-745 or placebo to evaluate safety, tolerability, and pharmacokinetics

1 week

Multiple Dose Treatment

Participants receive multiple oral doses of ABP-745 or placebo to evaluate safety, tolerability, and pharmacokinetics

2-4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABP-745

Trial Overview 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).

How Is the Trial Designed?

Group I: ABP-745 Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

Lead Sponsor

Trials

7

Recruited

880+

Atom Therapeutics Co., Ltd

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07145229

Safety and Efficacy of ABP-745 in Participants With an ... A randomized, double-blind, international multicenter, colchicine and placebo-controlled study to evaluate the efficacy and safety of ...

2. clinicaltrial.be clinicaltrial.be/en/details/425478?per_page=100&only_recruiting=0&only_eligible=0&only_active=0

A Study to Evaluate the Safety, Tolerability, and Pharmac... This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ABP-745 following single (Part 1) and multiple (Part 2) oral ...

3. firstwordpharma.com firstwordpharma.com/story/6327776

Atom Therapeutics to Present Positive Data from Clinical ... The Phase 1 study of ABP-745 in healthy volunteers demonstrated the drug was well-tolerated and exhibited dose proportional pharmacokinetics ...

4. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/atom-therapeutics-global-phase-ii-trial-novel-anti-inflammatory-treatment-acute-gout-flares

Atom Therapeutics Launches Global Phase II Trial of Novel ... Invesigators will evaluate the safety, efficacy, and pharmacodynamics of ABP-745 in reducing pain and swelling during acute gout flares, with ...

5. withpower.com withpower.com/trial/phase-1-gout-2024-3d69a

ABP-745 Safety Study in Healthy Volunteers 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.

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/461045

A Study to Evaluate the Safety, Tolerability, and ... A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Oral ABP-745 Administration in Healthy Volunteers. Phase. I. Age. 18-55.

7. finance.yahoo.com finance.yahoo.com/news/atom-therapeutics-present-positive-data-093000749.html

Atom Therapeutics to Present Positive Data from Clinical ... Data from a Phase 1 trial of ABP-745, an anti-inflammatory drug for ... safety profile and good pharmacokinetics in healthy volunteers.