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This study is a single center, randomized, double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM559 administered intravenously at different doses in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM559 or matched placebo cohort 1 | Experimental |
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| CM559 or matched placebo cohort 2 | Experimental |
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| CM559 or matched placebo cohort 3 | Experimental |
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| CM559 or matched placebo cohort 4 | Experimental |
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| CM559 or matched placebo cohort 5 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo injection administered IV, once. |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability of single dose administration of CM559 in healthy male subjects: Adverse events (AEs), physical examinations, vital signs, 12-lead electrocardiograms (ECGs), magnetic resonance imaging (MRI), laboratory tests, etc. | All adverse events (AEs) collected from all subjects from the time of signing the informed consent form (ICF) to the completion of the study (or early withdrawal), including clinical manifestations, severity, occurrence time, end time, treatment measures, and outcomes, as well as their correlation with the investigational drug. Any clinically significant abnormalities found during the physical examinations, vital signs examination, ECGs examinations and laboratory tests. The proportion of subjects experienced amyloid-related imaging abnormalities (ARIA) identified by MRI. | Up to 99 Days |
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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 |
|---|---|---|
| Mengchang Yang | Sichuan Provincial People's Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | China |
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| CM559 | Biological | CM559 injection administered IV, once. |
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