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| Name | Class |
|---|---|
| Huashan Hospital | OTHER |
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This is a Phase 1, first time in human study enrolling approximately 42 healthy adult subjects (18-45 yrs) from one study site. The purpose of this study is to evaluate the safety, tolerability and PK of MW14 in healthy adult volunteers administered as a single IV dose compared with placebo, across 5 cohorts. The 5 dose cohorts will enroll sequentially. Subjects will be followed for safety from the time of Informed Consent through 85 days post dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9MW1411 injection | Experimental |
| |
| 9MW1411 injection placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9MW1411 injection | Combination Product | 9MW1411 injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event | safety evaluation | 12 weeks |
| Serious Adverse Event | safety evaluation | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Prior or current medical conditions:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital Fudan University | Shanghai | Shanghai Municipality | 200040 | China |
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| ID | Term |
|---|---|
| D013203 | Staphylococcal Infections |
| ID | Term |
|---|---|
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| 9MW1411 injection placebo |
| Combination Product |
9MW1411 injection placebo |
|