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This is Single-center, randomized, open-label, single-dose, two-period crossover study design.
The goal is to preliminary evaluate the PK comparability of TJ101 injection before and after CMC change following a single subcutaneous injection of 1.2 mg/kg in healthy male subjects in China, and to assess whether the two formulations are bio equivalent.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A(T-R) | Experimental |
| |
| Group B(R-T) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TJ101 injection Test Product | Drug | 1.2 mg/kg, administered by subcutaneous injection in the abdomen,Once per cycle |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary PK endpoint: Cmax | Maximum Concentration | 10 days after dosing |
| Primary PK endpoint: AUC0-inf | Area Under the Concentration-Time Curve from Time Zero to Infinity | 10 days after dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chengdu Xinhua Hospital | Chengdu | Sichuan | China |
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| TJ101 injection Reference Product | Drug | 1.2 mg/kg, administered by subcutaneous injection in the abdomen,Once per period |
|