BMS-986447 Safety and Tolerability for Healthy Subjects

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Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Bristol-Myers Squibb

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new drug, BMS-986447, by administering it in single, oral doses to healthy participants. Researchers seek to understand how the body processes this drug and ensure it does not cause unwanted side effects. Participants will receive either the actual drug or a placebo, a harmless pill resembling the drug. Individuals who are healthy, with a body mass index (BMI) between 18 and 30 and no significant health issues, may be suitable for this trial. 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 whether you need to stop taking your current medications. However, since the study is for healthy participants, it's likely that you should not be on any regular medications. Please check with the study coordinators for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that BMS-986447 is a new drug under study to determine its safety for human use. Detailed information about its safety in humans remains limited because it is still in the early testing phase. This stage ensures the drug's safety before testing it on more people or those with specific health conditions.

Participants take the drug as a single oral dose, swallowing it just once. This helps researchers understand how the body processes the drug and if any side effects occur. Since this is the first human test, the main focus is on safety and tolerance. During these early tests, researchers closely monitor participants to quickly identify and manage any negative reactions.

If the drug shows a good safety profile in these studies, it may proceed to further testing. For now, BMS-986447 remains in the early stages of understanding its safety in humans.12345

Why do researchers think this study treatment might be promising?

BMS-986447 is unique because it offers a new approach to treatment by potentially improving safety and tolerability for patients. Unlike most current treatment options, which often focus on symptom management, BMS-986447 may work by targeting underlying mechanisms in a novel way, though specific details about its mechanism of action are still being explored. Researchers are excited about this treatment due to its potential to provide a safer option with fewer side effects, making it appealing for individuals looking for better-tolerated therapies.

What evidence suggests that BMS-986447 could be effective?

Research on BMS-986447 remains in the early stages, so direct proof of its effectiveness for specific health issues in people is not yet available. This trial will compare BMS-986447 with a placebo to understand how the drug behaves in the body, including its absorption, duration of activity, and processing by the body. Scientists are carefully observing participants' reactions to ensure safety and tolerability. Although solid data on its effectiveness for any particular condition is not yet available, these early studies are crucial for guiding future research.12345

Who Is on the Research Team?

BS

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for healthy men and women with a body mass index (BMI) between 18 and 30. Participants must have no significant medical issues based on their history, physical exams, ECGs, or lab tests. They also need to test negative for COVID-19 before starting the study.

Inclusion Criteria

Body mass index between 18 and 30 kilograms per metered square (kg/m^2), inclusive
I have tested negative for COVID-19 as required.
I am healthy with no significant medical issues based on recent exams and tests.

Exclusion Criteria

I haven't had major surgery, or plan to have any, except for GI surgery, within the last 12 weeks.
Participant has any condition that confounds the ability to interpret data from the study
Participant has any condition including the presence of laboratory abnormalities, which places the participant at unacceptable risk if the participant was to participate in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single, oral doses of BMS-986447 or placebo

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • BMS-986447
  • Placebo
Trial Overview The study is testing BMS-986447, which participants will take as a single oral dose. The goal is to see how safe it is, how well people can tolerate it, and how the drug levels change in the body over time. Some participants will receive a placebo instead of the actual drug.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: BMS-986447Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

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 profile image

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 profile image

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

A Study to Evaluate the Safety, Tolerability and Drug ...The purpose of the study is to evaluate the safety, tolerability and drug levels of single, oral doses of BMS-986447 in healthy participants. Official Title. A ...
A Study to Evaluate the Safety, Tolerability and Drug Levels of ...The purpose of the study is to evaluate the safety, tolerability and drug levels of single, oral doses of BMS-986447 in healthy ...
BMS-986447 Safety and Tolerability for Healthy SubjectsThis trial is for healthy men and women with a body mass index (BMI) between 18 and 30. Participants must have no significant medical issues based on their ...
A Study to Evaluate the Safety, Tolerability and Drug ...The purpose of the study is to evaluate the safety, tolerability and drug levels of single, oral doses of BMS-986447 in healthy participants.
Trial ID IM054-003 | NCT05760937 - BMS Clinical TrialsThe purpose of the study is to evaluate the safety, tolerability and drug levels of single, oral doses of BMS-986447 in healthy participants.
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