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The purpose of this study is to assess how fast BGM0504 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group (Healthy Control) | Experimental |
| |
| B group (Mild Renal Impairment) | Experimental |
| |
| C group (Moderate Renal Impairment) | Experimental |
| |
| D group (Severe Renal Impairment) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BGM0504 | Drug | Receive a single dose of BGM0504 injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Tlast (AUC0-t) | Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Tlast (AUC0-t) | Start of Treatment up to Day 29 |
| Maximum Concentration of BGM0504 (Cmax) | Maximum Concentration of BGM0504 (Cmax) | Start of Treatment up to Day 29 |
| Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Infinity (AUC0-inf) | Area Under the Concentration Versus Time Curve (AUC) of BGM0504 From Time Zero to Infinity (AUC0-inf) | Start of Treatment up to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum concentration (Tmax) | Time to maximum concentration (Tmax) | Start of Treatment up to Day 29 |
| Apparent terminal half-life (t1/2) | Apparent terminal half-life (t1/2) |
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Inclusion Criteria:
√ Age 18-65 years on the date of signing informed consent (inclusive);
Body mass index (BMI) within the range of 19.0-30.0 kg/m2 (inclusive);.
Stable renal function, assessed by two eGFR during screening (apart at least 3 days);
Diagnosed as stable, chronic renal disease for at least 3 months.
Renal function, assessed by estimated glomerular filtration rate at screening (eGFR):
Exclusion Criteria:
● Allergic constitution includes severe drug allergy or history of drug allergy;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital, Shandong Province) | Jinan | Shandong | 650100 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| BGM0504 |
| Drug |
Receive a single dose of BGM0504 injection |
|
| BGM0504 | Drug | Receive a single dose of BGM0504 injection |
|
| BGM0504 | Drug | Receive a single dose of BGM0504 injection |
|
| Start of Treatment up to Day 29 |
| Apparent clearance (CL/F) | Apparent clearance (CL/F) | Start of Treatment up to Day 29 |
| Incidence and severity of adverse events | Incidence and severity of adverse events | Screening period up to Day 29 |
| D004700 | Endocrine System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |