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| Name | Class |
|---|---|
| BrightGene Pharmaceutical Co., Ltd. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BGM1812(Part A) | Experimental | Single ascending doses of BGM1812 administered subcutaneously (SC) |
|
| Placebo (Part A) | Placebo Comparator | Placebo administered SC |
|
| BGM1812 (Part B) | Experimental | Multiple ascending doses of BGM1812 administered SC. |
|
| Placebo (Part B) | Placebo Comparator | Placebo administered SC. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGM1812 | Drug | AdministeredSC |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to Study Completion (Up to 6-9weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK): Maximum Concentration (Cmax) of BGM1812 | PK Cmax of BGM1812 | Baseline to Study Completion (Up to 6-9weeks) |
| PK: Area Under the Concentration Versus Time Curve (AUC) of BGM1812 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Yunnan University of Chinese Medicine | Recruiting | Kunming | Yunnan | 650000 | China |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Drug |
Administered SC |
|
| BGM1812 | Drug | Administered SC |
|
| Placebo | Drug | Administered SC |
|
PK:AUC of BGM1812
| 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 | 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 | 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 | 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 | 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 | 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. | Baseline to Study Completion (Up to 6-9weeks) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |