BMS-986447 Safety and Tolerability for Healthy Subjects
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive single, oral doses of BMS-986447 or placebo
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BMS-986447
- Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
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