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This study is designed to access the tolerability and Pharmacokinetic/Pharmacodynamic (PK/PD) of single subcutaneous (SC) injection of GW003 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ic-GW003 150ug/kg 4-8subjects | Experimental | Biological/Vaccine:GW003 freeze-dried powder single SC injection |
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| Ic-GW003 300ug/kg 6-8subjects | Experimental | Biological/Vaccine:GW003 freeze-dried powder single SC injection |
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| Ic-GW003 500ug/kg 6-8subjects | Experimental | Biological/Vaccine:GW003 freeze-dried powder single SC injection |
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| Ic-GW003 650ug/kg 6-8subjects | Experimental | Biological/Vaccine:GW003 freeze-dried powder single SC injection |
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| Ic-GW003 850ug/kg 6-8subjects | Experimental | Biological/Vaccine:GW003 freeze-dried powder single SC injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GW003 | Biological | single SC injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | To evaluate the safety and tolerance of single SC injection of GW003 in healthy subjects. | up to day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of subjects with Anti-GW003 antibody | anti-GW003 was detected pre-dose and at the last visit,if there exist positive anti-GW003 antibody, another detected should be conducted 6 months after the trial. | up to 6 months after the trial |
| half-life(consist of distribution and elimination half-life) for GW003 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Qi Junyuan, doctor | Tianjin Hematonosis Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Hematonosis Hospital | Tianjin | Tianjin Municipality | 30020 | China |
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| up to day 14 |
| area under the concentration-time curve(AUC) for GW003 | up to day 14 |