BMS-986521 for Healthy Subjects

Overseen By BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Cancer, Rhabdomyolysis, GI disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Up to approximately 11 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new drug called BMS-986521 to assess its safety and how the body processes it. Researchers are also examining whether food affects the drug's efficacy. This trial is for healthy adults who cannot have children and have no significant health issues. Participants should maintain a stable body weight and have a BMI between 18 and 32. Those with a stable heart condition might still qualify for one part of the study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since the trial is for healthy participants without significant medical conditions, it's likely that you should not be on any regular medications. Please check with the trial organizers for specific guidance.

Is there any evidence suggesting that BMS-986521 is likely to be safe for humans?

Research has shown that BMS-986521 is being tested for safety in healthy adults. This treatment is in the early testing stages, so detailed safety information is limited. Researchers assess reactions to different doses and monitor for side effects. Early studies typically begin with low doses to ensure safety, gradually increasing to determine tolerance levels. This process helps identify potential side effects and assess treatment tolerance. As this study is in the first phase, researchers closely monitor and evaluate safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about BMS-986521 because it targets the condition in a novel way, potentially offering benefits over existing treatments. Unlike standard therapies that might rely on traditional pathways, BMS-986521 employs a unique mechanism of action that could enhance its effectiveness or reduce side effects. This innovative approach could lead to faster or more sustained results, making it a promising option for patients in the future.

What evidence suggests that BMS-986521 could be effective?

Research on BMS-986521 focuses on assessing its safety and understanding how the body processes the drug. Since testing occurs in healthy individuals across various treatment arms, information on its effectiveness for specific health problems remains limited. Understanding how BMS-986521 functions in the body is a crucial first step before evaluating its potential benefits for actual health issues. Currently, no solid proof exists that it effectively treats any specific condition. This study will determine if it’s safe enough to proceed to tests that could measure its benefits. ^{1 3 6 7 8}

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for healthy adults who can participate in a study to test the safety and tolerability of a new drug, BMS-986521. Key eligibility details are not provided, so general good health is assumed.

Inclusion Criteria

For Part B/Cohort 11 only: participants with stable cardiovascular conditions may be included if deemed suitable by the investigator

My BMI is between 18 and 32, and I weigh at least 50 kg.

I am healthy, not able to have children, and have no significant medical issues.

Exclusion Criteria

I do not have any major health issues that could affect how a drug works in my body.

I have never had rhabdomyolysis, cancer (except certain skin or cervical cancers), blood cancer, or myelodysplastic syndrome.

I haven't had recent GI issues or surgeries affecting drug absorption, except for appendix or gallbladder removal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and multiple ascending doses of BMS-986521 to evaluate safety, tolerability, and pharmacokinetics

Up to approximately 11 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BMS-985521

Trial Overview

The study tests BMS-986521 by giving participants either this drug or a placebo. It looks at how safe it is and how the body handles different doses over time, including with and without food.

How Is the Trial Designed?

Group I: Part C Experimental Treatment 1 Intervention

Group II: Part B Cohort 9 Experimental Treatment 2 Interventions

Group III: Part B Cohort 8 Experimental Treatment 2 Interventions

Group IV: Part B Cohort 7 Experimental Treatment 2 Interventions

Group V: Part B Cohort 11 Experimental Treatment 2 Interventions

Group VI: Part B Cohort 10 Experimental Treatment 2 Interventions

Group VII: Part A Cohort 6 Experimental Treatment 2 Interventions

Group VIII: Part A Cohort 5 Experimental Treatment 2 Interventions

Group IX: Part A Cohort 4 Experimental Treatment 2 Interventions

Group X: Part A Cohort 3 Experimental Treatment 2 Interventions

Group XI: Part A Cohort 2 Experimental Treatment 2 Interventions

Group XII: Part A Cohort 1 Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania

Citations

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clinicaltrials.gov

clinicaltrials.gov/study/NCT07283263

A Study to Evaluate the Safety, Tolerability, and Drug ...

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending ...

2.

trial.medpath.com

trial.medpath.com/clinical-trial/2e2c8f11852840b2/nct07283263-phase1-bms986521-safety-tolerability-pharmacokinetics

A Study to Evaluate the Safety, Tolerability, and Drug Levels of ...

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending ...

3.

bmsstudyconnect.com

bmsstudyconnect.com/cz/en/clinical-trials/NCT07283263.html

A Study to Evaluate the Safety, Tolerability, and Drug Levels of ...

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02763969

Safety Study of BMS-986202 in Healthy Subjects and to ...

There are three types of violations: Failure to submit required clinical trial information; Submission of false or misleading clinical trial information ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9260471/

Recommendations for the use of propensity score methods in ...

We summarize recommendations on the use of propensity score matching and weighting based on the current methodological literature, and provide examples of good ...

6.

ctv.veeva.com

ctv.veeva.com/study/a-study-to-evaluate-the-safety-tolerability-and-drug-levels-of-bms-986521-in-healthy-participants

A Study to Evaluate the Safety, Tolerability, and Drug Levels of ...

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending ...

7.

bmsstudyconnect.com

bmsstudyconnect.com/ch/fr/clinical-trials/NCT07283263.html

A Study to Evaluate the Safety, Tolerability, and Drug Levels of ...

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending doses of ...

8.

bmsclinicaltrials.com

bmsclinicaltrials.com/cl/es/clinical-trials/NCT07283263

ID del estudio CN014-0001 - BMS Clinical Trials

The purpose of this study is to evaluate the safety, tolerability, and drug levels of BMS-986521 following single and multiple ascending doses of ...