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| Name | Class |
|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
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This study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of the investigational drug Supaglutide proposed dosing once (or twice) weekly in Chinese healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.15mg Supaglutide or placebo | Experimental | 0.15 milligrams (mg) Supaglutide injection or placebo administered once subcutaneously(SC) to healthy participants |
|
| 0.375mg Supaglutide or placebo | Experimental | 0.375 milligrams (mg) Supaglutide injection or placebo administered once subcutaneously(SC) to healthy participants |
|
| 0.75mg Supaglutide or placebo | Experimental | 0.75 milligrams (mg) Supaglutide injection or placebo administered once subcutaneously(SC) to healthy participants |
|
| 1.5mg Supaglutide or placebo | Experimental | 1.5 milligrams (mg) Supaglutide injection or placebo administered once subcutaneously(SC) to healthy participants |
|
| 3.0mg Supaglutide or placebo | Experimental | 3.0 milligrams (mg) Supaglutide injection or placebo administered once subcutaneously(SC) to healthy participants |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supaglutide injection | Drug | Administered SC in the Supaglutide arms. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic:Cmax of Supaglutide | Maximum Concentration(Cmax) of Supaglutide | baseline and up to 29 days after formal dose |
| Pharmacokinetic: Tmax of Supaglutide | Time to maximum plasma concentration (Tmax) | baseline and up to 29 days after formal dose |
| Pharmacokinetic: AUC0-t of Supaglutide | Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t) | baseline and up to 29 days after formal dose |
| Pharmacokinetic: t½ of Supaglutide | Terminal elimination half-life in plasma (t½) | baseline and up to 29 days after formal dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39961992 | Derived | Lou YR, Xu YL, Xiong Y, Deng C, Wang Q. Population Pharmacokinetics of Efsubaglutide Alfa in Healthy Subjects and Subjects with Type 2 Diabetes. Clin Pharmacokinet. 2025 Apr;64(4):533-552. doi: 10.1007/s40262-025-01475-7. Epub 2025 Feb 17. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo | Drug | Administered SC in the placebo arms and to maintain the blind in the Supaglutide injection arms. |
|
| D004700 | Endocrine System Diseases |