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SHR-1703 is a monoclonal antibody under development for severe asthma. This study is the first study in patients with asthma. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics ,pharmacodynamics and immunogenic characteristics of multiple subcutaneous injections of SHR-1703 in asthmatic patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Placebo Comparator |
| |
| Treatment group C | Experimental |
| |
| Treatment group D | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1703 | Drug | SHR-1703 low dose |
| |
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse events of SHR-1703 | From Day 1 to Day 281 | |
| Severity of adverse events of SHR-1703 | From Day 1 to Day 281 | |
| Tolerability of adverse events of SHR-1703 | From Day 1 to Day 281 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the concentrations of multiple subcutaneous injections of SHR-1703 in asthmatic patients | From Day 1 to Day 281 | |
| The percentage change of absolute eosinophil count from baseline | From Day 1 to Day 281 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital of Sichuan University | Chengdu | Sichuan | 610044 | China |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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SHR-1703 low dose VS. placebo low dose. SHR-1703 high dose VS. placebo high dose
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| Drug |
placebo low dose |
|
| SHR-1703 | Drug | SHR-1703 high dose |
|
| placebo | Drug | placebo high dose |
|
| Incidence of SHR-1703 immunogenicity | From Day 1 to Day 281 |
| Occurrence time of SHR-1703 immunogenicity | From Day 1 to Day 281 |
| Duration of anti drug antibody (ADA) of SHR-1703 | From Day 1 to Day 281 |
| Titer of anti drug antibody (ADA) of SHR-1703 | From Day 1 to Day 281 |
| The percentage change of forced expiratory volume in 1 second from baseline | From Day 1 to Day 281 |
| The percentage change of forced vital capacity from baseline | From Day 1 to Day 281 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |