A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986454 in Healthy Participants
- Registration Number
- NCT06086886
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the safety and tolerability of BMS-986454 in healthy adult participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
Inclusion Criteria
- Male and female participants who are healthy as determined by the investigator based on review of medical history, physical examinations, 12-lead ECGs, and clinical laboratory tests obtained during the screening period.
- Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
- A negative test for COVID-19, which will be performed in the manner mandated by the clinical site where this study is being conducted, at screening and admission.
Exclusion Criteria
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory tests beyond what is consistent with a healthy population in the region in which the study is conducted.
- Participant was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever is longer).
- Inability to be venipunctured or tolerate venous access.
Note: Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Placebo Placebo - BMS-986454 BMS-986454 -
- Primary Outcome Measures
Name Time Method Number of participants with clinical laboratory abnormalities Up to approximately 4 months Number of participants with physical examination abnormalities Up to approximately 4 months Number of participants with vital sign abnormalities Up to approximately 4 months Number of participants with adverse events (AEs) Up to approximately 4 months Number of participants with severe adverse events (SAEs) Up to approximately 4 months Number of participants with electrocardiogram (ECG) abnormalities Up to approximately 4 months
- Secondary Outcome Measures
Name Time Method Maximum observed serum concentration (Cmax) Up to approximately 3 months Time of maximum observed serum concentration (Tmax) Up to approximately 3 months Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)] Up to approximately 3 months Incidence of anti-drug antibody (ADA) formation Up to approximately 3 months Absolute Bioavailability (F) of BMS-986454 Up to approximately 3 months
Trial Locations
- Locations (2)
Local Institution - 0001
🇬🇧Nottingham, United Kingdom
Local Institution - 0002
🇬🇧London, Greater London, United Kingdom