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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
The First Affiliated Hospital of Yunnan University of Chinese Medicine
Kunming, Yunnan, China
RECRUITINGNumber 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
Time frame: Baseline to Study Completion (Up to 6-9weeks)
Pharmacokinetic (PK): Maximum Concentration (Cmax) of BGM1812
PK Cmax of BGM1812
Time frame: Baseline to Study Completion (Up to 6-9weeks)
PK: Area Under the Concentration Versus Time Curve (AUC) of BGM1812
PK:AUC of BGM1812
Time frame: Baseline to Study Completion (Up to 6-9weeks)
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
Time frame: Baseline to Study Completion (Up to 6-9weeks)
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
Time frame: Baseline to Study Completion (Up to 6-9weeks)
PD: Insulin of BGM1812
PD: Changes in insulin before and after administration, and differences in the amount of change among different dose groups
Time frame: Baseline to Study Completion (Up to 6-9weeks)
PD: Body Weight of BGM1812
PD: Changes in body weight before and after administration, and differences in the amount of change among different dose groupsPD: Changes in body weight before and after administration, and differences in the amount of change among different dose groups
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Administered SC
Time frame: Baseline to Study Completion (Up to 6-9weeks)
PD: Waist Circumference of BGM1812
PD: Changes in waist circumference before and after administration, and differences in the amount of change among different dose groups
Time frame: Baseline to Study Completion (Up to 6-9weeks)
Immunogenicity Endpoints
Detect the anti-drug antibodies (ADA) of the study drug and their titers; if the ADA is positive, neutralizing antibodies (NAb) will be further detected.
Time frame: Baseline to Study Completion (Up to 6-9weeks)