BMS-986446 for Healthy Subjects

Recruiting at 2 trial locations

Overseen By BMS Study Connect Contact Center, www.BMSStudyConnect.com

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Gastrointestinal, Renal, Hepatic, Neurological, others

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

Compensation: Varies

Number of Visits: 85

Duration: 1 day

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to assess drug levels, tolerability and absolute biological availability of single subcutaneous dose of BMS-986446 in healthy participants

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.

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

Participants must have a Body Mass Index (BMI) of 18.0 to 30.0 kg/m2

I am healthy based on recent medical exams and tests.

Exclusion Criteria

I have never been treated with BMS-986446 (PRX005).

Other protocol-defined Inclusion/Exclusion criteria apply

I do not have any major ongoing health issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subcutaneous dose of BMS-986446

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Multiple visits (in-person and virtual) up to Day 85

What Are the Treatments Tested in This Trial?

Interventions

• BMS-986446

Trial Overview The study tests the levels and tolerability of a single dose of BMS-986446 administered subcutaneously (under the skin) in healthy participants. It also compares this method with intravenous administration and includes common medications like Acetaminophen and Loratadine.

How Is the Trial Designed?

Group I: Arm B Experimental Treatment 3 Interventions

Group II: Arm A Experimental Treatment 3 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