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This study is a Phase I, single-center, randomized, open-label, parallel-controlled study, aimed at evaluating the pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability of a single dose of CM383 administered via intravenous infusion or subcutaneous injection in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM383 subcutaneous injection group 1 | Experimental |
| |
| CM383 subcutaneous injection group 2 | Experimental |
| |
| CM383 intravenous infusion group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM383 | Biological | CM383 subcutaneous injection, once. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic characteristics of a single-dose administration of CM383 in healthy male subjects | Pharmacokinetic concentrations in serum and pharmacokinetic parameters: maximum concentration (Cmax). | Up to Day 85 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Jia | Contact | 028-88610620 | qianjia@keymedbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Bo Jiang | The Second Affiliated Hospital Zhejiang University School of Medcine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medcine | Recruiting | Hangzhou | China |
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| CM383 | Biological | CM383 intravenous infusion, once. |
|