Healthy Participants
Conditions
Keywords
Pharmacokinetics, Pharmacodynamics, Healthy Participants, BMS-986454, First-in-human, Safety
Brief summary
The purpose of this study is to assess the safety and tolerability of BMS-986454 in healthy adult participants.
Interventions
DRUGBMS-986454
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with severe adverse events (SAEs) | Up to approximately 4 months |
| Number of participants with adverse events (AEs) | 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 electrocardiogram (ECG) abnormalities | Up to approximately 4 months |
| Number of participants with clinical laboratory abnormalities | Up to approximately 4 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed