The purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of BMS-986325 in healthy participants and participants with primary Sjögren's syndrome. The results will guide the future clinical development with BMS-986325.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
118
Specified dose on specified days
Specified dose on specified days
Medvin Clinical Research - Metyas
Covina, California, United States
Local Institution - 0001
Berlin, Germany
Incidence of Adverse Events (AEs)
Time frame: Up to 137 days
Incidence of clinically significant changes in clinical laboratory results: Hematology tests
Time frame: Up to 137 days
Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests
Time frame: Up to 137 days
Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests
Time frame: Up to 137 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 137 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 137 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 137 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 137 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
PR interval: The time from the onset of the P wave to the start of the QRS complex
Time frame: Up to 137 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval
QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization
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Time frame: Up to 137 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
QT interval: Measured from the beginning of the QRS complex to the end of the T wave
Time frame: Up to 137 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval
QTcF interval: Corrected QT interval using Fridericia's formula (QTcF)
Time frame: Up to 137 days
Incidence of clinically significant changes in physical examination findings
Time frame: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: C-reactive protein (CRP)
Time frame: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interferon-gamma (IFN-γ)
Time frame: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interleukin-1 beta (IL-1β)
Time frame: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interleukin-6 (IL-6)
Time frame: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Interleukin-8 (IL-8)
Time frame: Up to 137 days
Incidence of clinically significant changes in inflammatory markers: Tumor necrosis factor alpha (TNFα)
Time frame: Up to 137 days
Maximum observed plasma concentration (Cmax)
Time frame: Up to 137 days
Time of maximum observed plasma concentration (Tmax)
Time frame: Up to 137 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))
Time frame: Up to 137 days