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This is a single center, double-blinded, placebo-controlled phase I clinical trail in healthy volunteer of meplazumab for injection. The primary objective of this phase I trial is to evaluate the safety, tolerability, pharmacokinetic characteristics and occupancy characteristics of peripheral blood cell receptors of meplazumab in healthy volunteer, and provide a reference for the dosage of meplazumab in phase II clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| meplazumab dose 1 | Experimental | 0.06mg/kg for single dose |
|
| meplazumab dose 2 | Experimental | 0.12mg/kg for single dose |
|
| meplazumab dose 3 | Experimental | 0.2mg/kg for single dose |
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| meplazumab dose 4 | Experimental | 0.3mg/kg for single dose |
|
| meplazumab dose 5 | Experimental | 0.42mg/kg for single dose |
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| meplazumab dose 6 | Experimental | 0.56mg/kg for single dose |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| meplazumab for injection | Drug | single dose: 6 dose level, multiple dose: 0.3mg/kg/dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate of treatment-related adverse events as assessed by CTCAE v5.0 | Nature, incidence, and severity of AEs/SAEs, and the relationship to meplazumab treatment. | 0-28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic assessments of meplazumab- AUC0-tn | AUC0-tn | 0-28 days |
| Pharmacokinetic assessments of meplazumab- AUC0-∞ | AUC0-∞ | 0-28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital of the Fourth Military Medical University | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| C000711810 | meplazumab |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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|
| meplazumab multiple dose | Experimental | 0.3mg/kg for double doses, 1 dose/week |
|
| Placebo | Drug | placebo |
|
| Pharmacokinetic assessments of meplazumab-half life time | 0-28 days |
| Pharmacokinetic assessments of meplazumab-Cmax | Maximum observed plasma concentration of meplazumab (Cmax) | 0-28 days |