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This study was a multi-center, randomized, double blind, placebo-controlled, single-dose, dose escalation Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CM338 with multiple dosing in healthy subjects.
The study included screening period, administration and safety follow-up period.
Forty-eight healthy volunteers will be enrolled and randomized into 4 groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CM338 75 mg, subcutaneous injection | Experimental | Qquaque week |
|
| CM338 150 mg, subcutaneous injection | Experimental | Qquaque week |
|
| CM338 300 mg, subcutaneous injection | Experimental | Qquaque week |
|
| CM338 300 mg, intravenous infusion | Experimental | Qquaque week |
|
| Placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM338 Injection | Biological | A humanized monoclonal antibody. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events (AEs). | Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. | Up to Week 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PKUCare Luzhong Hospital | Zibo | China |
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