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This is a Phase 1, randomized, placebo-controlled study, enrolling approximately 38 healthy adult subjects (18-65 yrs). The purpose of this study is to evaluate the safety, tolerability and PK of single ascending dose of 9MW1911 administered intravenously (IV) in healthy adult volunteers. All subjects will be followed up for safety from the time of Informed Consent through 113 days post dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 9MW1911 Injection | Active Comparator | Experimental drug administered IV infusion |
|
| 9MW1911 Injection Placebo | Placebo Comparator | Placebo administered IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 9MW1911 Injection | Drug | Single dose intravenously on day 1 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event(including serious adverse event) | The incidence of AEs (adverse events) and SAEs (serious adverse events) from treatment until the last scheduled follow-up visit | up to day 113 |
| Measure | Description | Time Frame |
|---|---|---|
| PK parameters | Maximum concentration(Cmax) | up to day 113 |
| PK parameters | The area under the curve (AUC) | up to day 113 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wang Shuhai, Ph.D | Mabwell (Shanghai) Bioscience Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Public Health Center | Shanghai | Shanghai Municipality | 200540 | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| 9MW1911 Injection Placebo |
| Drug |
Single dose of matching placebo intravenously on day 1 |
|
| PK parameters | Time at which maximum concentration(Tmax) | up to day 113 |
| PK parameters | The half life(T1/2) | up to day 113 |
| Incidence of ADAs Against 9MW1911 | The incidence of ADAs against 9MW1911 during the study will be summarized | up to day 113 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |