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This open-label, randomized, three-period crossover, 8-hour hyperinsulinemic-euglycemic clamp study will compare the pharmacokinetic and pharmacodynamic profiles of THDB0206 after single subcutaneous administration at different injection sites in healthy Chinese adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THDB0206 injection-Upper Arm | Experimental |
| |
| THDB0206 injection-Abdomen | Experimental |
| |
| THDB0206 injection-Thigh | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THDB0206 injection-Upper arm | Drug | Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the upper arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCLisp(0-inf) | Area under the insulin lispro plasma concentration-time curve from zero to infinity | From 0 to 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax (Lisp) | The maximum plasma concentration of insulin lispro observed | From 0 to 8 hours |
| AUCLisp | Area under the insulin lispro plasma concentration-time curve |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Sichuan | China |
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| THDB0206 Injection-Abdomen | Drug | Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the abdomen. |
|
| THDB0206 Injection-Thigh | Drug | Subjects received a single subcutaneous injection of THDB0206 at a dose of 0.2 U/kg in the thigh. |
|
| From 0 to 8 hours |
| tmax(Lisp) | Time to reach the maximum insulin lispro plasma concentration | From 0 to 8 hours |
| t1/2 | Terminal half-life | From 0 to 8 hours |
| CL/F | CL/F | From 0 to 8 hours |
| Vz/F | Apparent volume of distribution | From 0 to 8 hours |
| AUCGIR | Area under the glucose infusion rate-time curve | From 0 to 8 hours |
| GIRtot | Total glucose infusion during clamping | From 0 to 8 hours |
| GIRmax | Maximum glucose infusion rate | From 0 to 8 hours |
| tGIRmax | Time to reach the maximum glucose infusion rate | From 0 to 8 hours |
| Number of participants with abnormal clinical laboratory findings (haematology, biochemistry and urinalysis) | From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration) |
| Number of participants with abnormal 12-lead ECG parameters (PR, QR, QRS intervals and QTc) | From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration) |
| Number of participants with abnormal vital signs (body temperature, supine blood pressure and pulse rate) | From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration) |
| Number of participants with abnormal physical examination (general condition, head and five sense organs, neck, chest, abdomen, spine and limbs, nervous system) | From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration) |
| Number of participants with hypoglycemia events in each treatment arm | From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration) |
| Number of participants with injection site reactions (spontaneous pain, tenderness, itching, redness, edema, induration/infiltration, and others) | From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration) |
| Number of participants with AE and SAE | From the first drug administration to the follow-up visit (3 to 10 days after the last drug administration) |