BMS-986446 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called BMS-986446, an experimental drug, to determine its absorption and tolerance in the body. The goal is to understand how the drug behaves when administered as a single dose under the skin. The trial seeks healthy individuals with a Body Mass Index (BMI) between 18 and 30 who are free from significant health issues. Participants must not have had prior exposure to BMS-986446. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new drug.
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 trial is for healthy participants, it's likely that you should not be on any regular medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that BMS-986446 has undergone safety testing in healthy individuals. One study found this treatment to be safe and well tolerated at three different dose levels, meaning participants did not experience major side effects. As an early-phase trial, the focus is primarily on identifying potential risks. So far, results suggest that BMS-986446 is generally safe for humans at the tested doses.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about BMS-986446 because it offers a new approach compared to standard treatments. Unlike traditional therapies that may target symptoms, BMS-986446 works by targeting a specific molecular pathway, potentially offering a more precise intervention. This new mechanism of action could lead to better outcomes with fewer side effects, which is a significant advantage over existing options. Additionally, its unique formulation might allow for more convenient dosing, improving patient adherence and experience.
What evidence suggests that BMS-986446 could be effective?
Research shows that BMS-986446 is designed to reduce the build-up of tau protein in the brain, which is important because tau protein clumps are linked to diseases like Alzheimer's. Lab studies have demonstrated that it can slow the spread of tau and may help activate beneficial brain processes. The FDA has fast-tracked this treatment, indicating its potential for treating conditions related to tau protein. Earlier trials showed it to be safe and well-tolerated in healthy people, but its main effectiveness is still under investigation. Participants in this trial will join one of two experimental arms to further evaluate the safety and effects of BMS-986446.13567
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 individuals with a BMI of 18.0 to 30.0 kg/m2, without prior exposure to BMS-986446 or significant health issues like gastrointestinal, renal, hepatic disorders, cancer, or ongoing allergies requiring treatment.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single subcutaneous dose of BMS-986446
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- BMS-986446
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