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This study is a single center, randomized, double-blind, placebo-controlled Phase I clinical study in a single dose escalation to evaluate its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM383 in male healthy subjects.
Alzheimer's disease (AD) is the most common type of dementia, which is a degenerative disease of the central nervous system with insidious onset and progressive development. Its clinical features mainly include memory impairment, cognitive impairment, psychobehavioral abnormalities, and social decline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | CM383 injection and matched placebo, intravenous injection |
|
| Group 2 | Experimental | CM383 injection and matched placebo, intravenous injection |
|
| Group 3 | Experimental | CM383 injection and matched placebo, intravenous injection |
|
| Group 4 | Experimental | CM383 injection and matched placebo, intravenous injection |
|
| Group 5 | Experimental | CM383 injection and matched placebo, intravenous injection |
|
| Group 6 | Experimental | CM383 injection and matched placebo, intravenous injection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM383 | Biological | CM383 Injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence of adverse events. | Up to week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Jia | Contact | 028-88610620 | qianjia@keymedbio.com | |
| Qing Wen | Contact | 13370551767 | wenq0619@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Qing Wen | Jinan Central Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jinan Central Hospital | Recruiting | Jinan | Shandong | China |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Placebo | Other | Placebo |
|
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |