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he goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2303 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2303 injection or placebo administration, with each Subjects will be enrolled in only one of these groups
This is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic profile of GR2303 Injection in healthy adult Chinese subjects.
After signing the informed consent form, subjects who meet the criteria for enrollment will be entered into different groups according to the randomization number. Subjects will be enrolled in only one of these groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | Experimental | single dose |
|
| group 2 | Experimental | single dose |
|
| group 3 | Experimental | single dose |
|
| group 4 | Experimental | single dose |
|
| group 5 | Experimental | single dose |
|
| group 6 | Experimental | multiple dose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GR2303 injection | Biological | single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | 16 weeks | |
| Tmax | 16 weeks | |
| t 1/2 | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nian | Contact | 021-50805989-08324 | nianhanli@genrixbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| group 7 | Experimental | multiple dose |
|
| group 8 | Experimental | multiple dose |
|
| Placebo | Biological | single dose |
|
| GR2303 injection | Biological | multiple dose |
|
| Placebo | Biological | multiple dose |
|
| ADA | 16 weeks |