The purpose of this study is to evaluate the tolerability , safety and pharmacodynamics of BGM1812 administered subcutaneously in healthy and non-diabetic overweight or obese Chinese participants, and to investigate the pharmacokinetic profile of BGM1812 in the bloodstream.
Between the ages of 18 and 65 years (inclusive) at the time of screening , healthy and non-diabetic overweight or obese subjects , both male and female;
Healthy subjects , male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 20.0 kg/m² ≤ BMI < 24 kg/m²（BMI = weight/height²）;
Obese individuals: BMI ≥ 28.0 kg/m², or overweight individuals: 24.0 kg/m² ≤ BMI < 28.0 kg/m²;
(Medical Inquiry) Have a stable body weight (<5% self-reported change during the previous 12 weeks) before screening.
Those with a history of severe drug allergies (especially those with known or suspected allergies to related compounds of BGM1812), or complicated with severe specific allergic diseases/history, or with a severe allergic constitution.
Subjects with positive results for HBsAg, anti-HCV, anti-HIV or anti-TP during the screening period.
12-lead ECG shows ventricular heart rate < 50 beats/min or > 100 beats/min at screening/baseline, second or third degree atrioventricular block, long QT syndrome, QTcF> 470ms for women or > 450ms for men, pre-excitation syndrome or other significant arrhythmias.
Used illegal drugs within 6 months prior to screening, or substance abuse within 12 months prior to screening.
Parallel
BGM1812
DrugAdministeredSC
Placebo
DrugAdministered SC
BGM1812
DrugAdministered SC
Placebo
DrugAdministered SC
Number of Participants with One or More Adverse Events (AEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator
Number of participants with AEs and SAEs will be assessed with reference to CTCAE V5.0
Pharmacokinetic (PK): Maximum Concentration (Cmax) of BGM1812
PK Cmax of BGM1812
PK: Area Under the Concentration Versus Time Curve (AUC) of BGM1812
PK:AUC of BGM1812
Pharmacodynamics (PD): Fasting Blood Glucose of BGM1812
PD: Changes in fasting blood glucosebefore and after administration, and differences in the amount of change among different dose groups
PD:C-Peptide of BGM1812
PD: Changes in C-peptide before and after administration, and differences in the amount of change among different dose groups
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BrightGene Bio-Medical Technology Co., Ltd.
Lead sponsor
BrightGene Pharmaceutical Co., Ltd.
Collaborator
