A Study to Evaluate the Drug Levels and Safety of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Multicenter, Placebo-Controlled, Randomized, Parallel, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pegbelfermin in Healthy Overweight and Obese Chinese and Korean Participants

Conditions
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Healthy Participants

Intervention / Treatment
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* Biological: BMS-986036
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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/exclusion criteria apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Dose 1 or placebo<br>Chinese participants | Biological: BMS-986036<br>* Specified dose on specified days<br>* Other names: Pegbelfermin;Other: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Cohort 2: Dose 2 or placebo<br>Chinese participants | Biological: BMS-986036<br>* Specified dose on specified days<br>* Other names: Pegbelfermin;Other: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Cohort 3: Dose 1 or placebo<br>Korean participants | Biological: BMS-986036<br>* Specified dose on specified days<br>* Other names: Pegbelfermin;Other: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Cohort 4: Dose 2 or placebo<br>Korean participants | Biological: BMS-986036<br>* Specified dose on specified days<br>* Other names: Pegbelfermin;Other: Placebo<br>* Specified dose on specified days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  | Up to 45 days | 
| Incidence of serious adverse events (SAEs) |  | Up to 70 days | 
| Incidence of clinically significant changes in vital signs: Body temperature |  | Up to 64 days | 
| 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 | PR interval is the time from the onset of the P wave to the start of the QRS complex | 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 | 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 | 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 | Up to 64 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chinese, Ethnicity, Korean, Obese, Overweight, Pegbelfermin