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To compare the pharmacokinetics and safety of HR17031 injection, SHR20004 injection and/or INS068 injection in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental | HR17031 injection dose+INS068 injection dose+SHR20004 injection dose+(INS068+SHR20004) injection dose |
|
| Treatment group B | Experimental | INS068 injection dose+(INS068+SHR20004)injection dose+ HR17031 injection dose +SHR20004 injection dose |
|
| Treatment group C | Experimental | SHR20004 injection dose+ HR17031 injection dose +(INS 068+SHR20004) injection dose+ INS068 injection dose |
|
| Treatment group D | Experimental | (INS 068+SHR20004) injection dose+ SHR20004 injection dose+ INS068 injection dose+ HR17031 injection dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HR17031 injection ;INS068 injection;SHR20004 injection | Drug | HR17031 injection dose+INS068 injection dose+SHR20004 injection dose+(INS068+SHR20004) injection dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax:Maximum observed concentration | Day1 to Day 26 | |
| AUC0-t :Area under the curve from the time of dosing time to the last measurable (positive) concentration; | Day1 to Day 26 | |
| AUC0-inf:Area under the curve from time 0 to infinity; | Day1 to Day 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax :time of maximum observed concentration | Day1 to Day 26 | |
| T1/2:Half-life time ; | Day1 to Day 26 | |
| CL/F |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
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| HR17031 injection ;INS068 injection;SHR20004 injection | Drug | INS068 injection dose+(INS068+SHR20004)injection dose+ HR17031 injection dose +SHR20004 injection dose |
|
| HR17031 injection ;INS068 injection;SHR20004 injection | Drug | SHR20004 injection dose+ HR17031 injection dose +(INS 068+SHR20004) injection dose+ INS068 injection dose |
|
| HR17031 injection ;INS068 injection;SHR20004 injection | Drug | (INS 068+SHR20004) injection dose+ SHR20004 injection dose+ INS068 injection dose+ HR17031 injection dose |
|
| Day1 to Day 26 |
| Vz/F | Day1 to Day 26 |
| Serum glucose within 24h after injection | Day1 to Day 23 |
| C-peptide concentrations within 24h after injection | Day1 to Day 23 |
| ADA:anti-drug antibody | Day 1、Day 8、Day15、Day 22 or early termination |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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