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This is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary pharmacodynamic characteristics of GR2301 injection in healthy adult subjects in China.The GR2301 injection dosage will be gradually increased. All healthy subjects will receive a single subcutaneous injection. Following administration, subjects will be followed for at least 16 weeks ± 7 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GR2301 injection 1 | Experimental | GR2301 injection dose 1/Placebo,Subcutaneous |
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| GR2301 injection 2 | Experimental | GR2301 injection dose 2/Placebo,Subcutaneous |
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| GR2301 injection 3 | Experimental | GR2301 injection dose 3/Placebo,Subcutaneous |
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| GR2301 injection 4 | Experimental | GR2301 injection dose 4/Placebo,Subcutaneous |
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| GR2301 injection 5 | Experimental | GR2301 injection dose 5/Placebo,Subcutaneous |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GR2301 injection | Biological | IL15 monoclonal antibody |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | Incidence of AEs | up to week16 |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics parameters | concentration of GR2301 | up to week16 |
| Incidence of ADA. | up to week16 |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| liaison officer | Contact | 18233161126 | shuxueye@genrixbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tongren Hospital Affiliated to Capital Medical University | Beijing | Beijing Municipality | China |
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