Clinical trial NCT06086886: A Study to Evaluate the Safety, Tolerability and Drug Levels of BMS-986454 in Healthy Participants
Official title: A Phase 1, Double-blinded, Randomized, Placebo-controlled, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Doses of BMS-986454 in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: Pharmacokinetics
Pharmacodynamics
Healthy Participants
BMS-986454
First-in-human
Safety
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-10-17
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and tolerability of BMS-986454 in healthy adult participants.


Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to approximately 4 months
measure: Number of participants with severe adverse events (SAEs)
timeFrame: Up to approximately 4 months
measure: Number of participants with physical examination abnormalities
timeFrame: Up to approximately 4 months
measure: Number of participants with vital sign abnormalities
timeFrame: Up to approximately 4 months
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to approximately 4 months
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to approximately 4 months
Secondary outcomes:
measure: Maximum observed serum concentration (Cmax)
timeFrame: Up to approximately 3 months
measure: Time of maximum observed serum concentration (Tmax)
timeFrame: Up to approximately 3 months
measure: Area under concentration time curve from time 0 to time of last quantifiable concentration [AUC(0-T)]
timeFrame: Up to approximately 3 months
measure: Incidence of anti-drug antibody (ADA) formation
timeFrame: Up to approximately 3 months
measure: Absolute Bioavailability (F) of BMS-986454
timeFrame: Up to approximately 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Local Institution - 0002
state: Greater London
city: Nottingham
country: United Kingdom
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: