Healthy Participants
Conditions
Keywords
Chinese, Ethnicity, Korean, Obese, Overweight, Pegbelfermin
Brief summary
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.
Interventions
BIOLOGICALBMS-986036
Specified dose on specified days
OTHERPlacebo
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Overweight and obese, but otherwise healthy Chinese and Korean participants, as determined by no clinically significant deviations from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations * Additional criterion for Chinese participants: must be first generation Chinese (born in China and not living outside of China for \> 10 years, and both parents are ethnically Chinese) * Additional criterion for Korean participants: must be first generation Korean (born in Korea and not living outside of Korea for \> 10 years, and both parents are ethnically Korean) * Must agree to follow specific methods of contraception, if applicable
Exclusion criteria
* BMI ≥ 40 kg/m\^2 * Women who are pregnant or breastfeeding * History of allergy to pegylated compounds or fibroblast growth factor 21-related compounds Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum observed plasma concentration (Cmax) of C-terminal intact BMS-986036 in Chinese and Korean participants | 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 | 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 | Up to 7 days after first dose and up to 7 days after last dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of clinically significant changes in vital signs: Respiratory rate | Up to 64 days | — |
| Incidence of clinically significant changes in vital signs: Blood pressure | Up to 64 days | — |
| Incidence of clinically significant changes in vital signs: Heart rate | Up to 64 days | — |
| Incidence of clinically significant changes in physical examination findings | Up to 64 days | — |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval | Up to 64 days | PR interval is the time from the onset of the P wave to the start of the QRS complex |
| Incidence of adverse events (AEs) | Up to 45 days | — |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval | Up to 64 days | The QT interval is the time from the start of the Q wave to the end of the T wave |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF | Up to 64 days | 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 |
| Incidence of clinically significant changes in clinical laboratory values: Hematology tests | Up to 64 days | — |
| Incidence of clinically significant changes in clinical laboratory values: Clinical chemistry tests | Up to 64 days | — |
| Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests | Up to 64 days | — |
| Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS | Up to 64 days | QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization |
| Incidence of serious adverse events (SAEs) | Up to 70 days | — |
| Incidence of clinically significant changes in vital signs: Body temperature | Up to 64 days | — |
Countries
China, South Korea
Outcome results
None listed