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This is a single-center, single-dose, open-label, positive-controlled, randomized, three-cycle, crossover 8-hour euglycemic clamp study to evaluate the PK, PD, safety and tolerability of THDB0206 injection after subcutaneous injection in healthy Chinese subjects. This trial will enroll 39 subjects to receive the investigational medicinal products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| THDB0206 injection | Experimental |
| |
| Humalog® | Active Comparator |
| |
| BC222insulin lispro injection | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| THDB0206 injection | Drug | 0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUCLisp(0-30 min) | Area under the insulin lispro plasma concentration-time curve from 0 to 30 minutes | From 0 to 30 minutes |
| 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:
Subjects who meet any of the following criteria will be excluded from the study:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Sichuan | China |
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| ID | Term |
|---|---|
| D061268 | Insulin Lispro |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Humalog® | Drug | 0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall |
|
| BC222insulin lispro injection | Drug | 0.2 U/kg, single-dose administration, subcutaneous injection 5 cm laterally from the belly button on the left or right side of the abdominal wall |
|
| 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 | Apparent clearance | 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) | 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) |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |