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The purpose of this study is to evaluate the pharmacokinetic profile and safety of a single subcutaneous injection of HDM1005 solution in participants with impaired kidney function compared to healthy participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 - Healthy Control | Experimental |
| |
| Group 2 - Moderate Renal Impairment | Experimental |
| |
| Group 3 - Severe Renal Impairment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HDM1005 | Drug | 2.0 mg, SC, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Concentration (Cmax) | Cmax of HDM1005 | Up to Day 29 |
| Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)] | AUC(0- t) of HDM1005 | Up to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Apparent clearance (CL/F) | CL/F of HDM1005 | Up to Day 29 |
| Apparent distribution(Vz/F) | Vz/F of HDM1005 | Up to Day 29 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Guiyu Liu | Contact | +86-0571 89908523 | liuguiyu@eastchinapharm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Beijing | 100191 | 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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| Adverse events (AEs) | Number of subjects reporting AEs | Up to Day 29 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |