Assessing drug levels and tolerability of BMS-986446 in healthy volunteers
A Phase 1, Randomized, Open-label, Parallel, Single-dose Study to Assess the Pharmacokinetics, Tolerability, and Absolute Bioavailability of Subcutaneous Administration of BMS-986446, an Anti-MTBR Tau Monoclonal Antibody, in Healthy Participants
This study tests how well a new drug called BMS-986446 is absorbed and tolerated by healthy volunteers after a single injection.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Bristol-Myers Squibb Industry-sponsored |
| Locations | 3 sites (Anaheim, California and 2 other locations) |
| Trial ID | NCT06955741 on ClinicalTrials.gov |
What this trial studies
This study evaluates the drug levels, tolerability, and absolute biological availability of a single subcutaneous dose of BMS-986446 in healthy participants. The study involves administering the drug and monitoring participants for any adverse effects and how well the drug is absorbed into the body. It aims to gather important pharmacokinetic data that could inform future studies and potential therapeutic uses of the drug.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 to 45 with a BMI between 18.0 and 30.0 kg/m2.
Not a fit: Patients with significant medical conditions or those who have previously been exposed to BMS-986446 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and effectiveness of BMS-986446, paving the way for its use in treating conditions related to tau pathology.
How similar studies have performed: Other studies assessing drug bioavailability and tolerability in healthy volunteers have shown success, indicating that this approach is well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must have a Body Mass Index (BMI) of 18.0 to 30.0 kg/m2. * Participants must be healthy as determined by medical history, physical examination, neurological examination, vital signs, 12-lead ECG, C-SSRS, and clinical laboratory evaluations. Exclusion Criteria: * Participants must not have clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, immune-mediated disorder, hematological, ongoing allergic disorder requiring treatment, metabolic disorder, cancer, or cirrhosis. * Participants must not have prior exposure to BMS-986446 (PRX005). * Other protocol-defined Inclusion/Exclusion criteria apply.
Where this trial is running
Anaheim, California and 2 other locations
- Anaheim Clinical Trials LLC (ACT) — Anaheim, California, United States (Recruiting)
- Local Institution - 10000 — Anaheim, California, United States (Not_yet_recruiting)
- Local Institution - 9999 — Anaheim, California, United States (Withdrawn)
Study contacts
- Study coordinator: BMS Study Connect Contact Center, www.BMSStudyConnect.com
- Email: Clinical.Trials@bms.com
- Phone: 855-907-3286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.