The purpose of this study is to evaluate the safety, tolerability, and drug level of Pegbelfermin in healthy overweight and obese Chinese and Korean participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Specified dose on specified days
Specified dose on specified days
Local Institution
Changchun, Jilin, China
Local Institution
Busan, South Korea
Maximum observed plasma concentration (Cmax) of C-terminal intact BMS-986036 in Chinese and Korean participants
Time frame: Up to 7 days after first dose and up to 7 days after last dose
Time of maximum observed plasma concentration (Tmax) of C-terminal intact BMS-986036 in Chinese and Korean participants
Time frame: Up to 7 days after first dose and up to 7 days after last dose
Area under the concentration-time curve over 1 dosing interval (AUC (TAU)) of C-terminal intact BMS-986036 in Chinese and Korean participants
Time frame: Up to 7 days after first dose and up to 7 days after last dose
Incidence of adverse events (AEs)
Time frame: Up to 45 days
Incidence of serious adverse events (SAEs)
Time frame: Up to 70 days
Incidence of clinically significant changes in vital signs: Body temperature
Time frame: Up to 64 days
Incidence of clinically significant changes in vital signs: Respiratory rate
Time frame: Up to 64 days
Incidence of clinically significant changes in vital signs: Blood pressure
Time frame: Up to 64 days
Incidence of clinically significant changes in vital signs: Heart rate
Time frame: Up to 64 days
Incidence of clinically significant changes in physical examination findings
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Time frame: Up to 64 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval
PR interval is the time from the onset of the P wave to the start of the QRS complex
Time frame: Up to 64 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS
QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Time frame: Up to 64 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval
The QT interval is the time from the start of the Q wave to the end of the T wave
Time frame: Up to 64 days
Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF
QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
Time frame: Up to 64 days
Incidence of clinically significant changes in clinical laboratory values: Hematology tests
Time frame: Up to 64 days
Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests
Time frame: Up to 64 days
Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests
Time frame: Up to 64 days