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This study is a randomized, parallel, open-label Phase I clinical trial aimed at comparing the bioavailability and safety of different specifications of SHR-3167 injection, with healthy subjects as the research subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-3167 Injection - Specification A Group | Experimental |
| |
| SHR-3167 Injection - Specification B Group | Experimental |
| |
| SHR-3167 Injection - Specification C Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-3167 Injection | Drug | SHR-3167 injection, different specifications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The maximum plasma concentration (Cmax) | Day 1 - Day 71. | |
| The area under the blood drug concentration-time curve corresponding from time 0 to the last quantifiable concentration time (AUC0-t) | Day 1 - Day 71. | |
| The area under the blood drug concentration-time curve from time 0 to infinity (AUC0-∞) | Day 1 - Day 71. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to maximum plasma concentration (Tmax) | Day 1 - Day 71. | |
| Terminal half-life (t1/2) | Day 1 - Day 71. | |
| Apparent volume of distribution (Vz/F) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanli Dong | Contact | +86-0518-82342973 | yanli.dong@hengrui.com | |
| Weijie Kong | Contact | +86-0518-82342973 | weijie.kong.wk1@hengrui.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiangya Hospital, Central South University | Recruiting | Changsha | Hunan | 410008 | China |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Day 1 - Day 71. |
| Safety: Incidence and severity of adverse events (AEs) | Day 1 - Day 71. |
| Anti-SHR-3167 antibody (ADA) | Day 1; Day 22; Day 71. |
| Apparent clearance (CL/F) | Day 1 - Day 71. |