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This study is a phase 1 single dose escalation study of SHR-1905 in healthy subjects and subjects with mild asthma. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1905 in healthy subjects and subjects with mild asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | A single subcutaneous injection of SHR-1905/placebo dose 1 in healthy subjects |
|
| Cohort 2 | Experimental | A single subcutaneous injection of SHR-1905/placebo dose 2 in healthy subjects |
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| Cohort 3 | Experimental | A single subcutaneous injection of SHR-1905/placebo dose 3 in healthy subjects |
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| Cohort 4 | Experimental | A single subcutaneous injection of SHR-1905/placebo dose 4 in healthy subjects |
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| Cohort 5 | Experimental | A single subcutaneous injection of SHR-1905/placebo dose 5 in healthy subjects |
|
| Cohort 6 | Experimental | A single subcutaneous injection of SHR-1905/placebo dose 6 in subjects with mild asthma |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1905/placebo | Drug | Drug: SHR-1905 subcutaneous, single dose Drug: Placebo subcutaneous, single dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence and severity of adverse events | Start of Treatment to end of study (approximately 16 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics-AUC0-last | Area under the concentration-time curve from time 0 to last time point after SHR-1905 administration | Start of Treatment to end of study (approximately 16 weeks) |
| Pharmacokinetics-AUC0-inf |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Xuhui Central Hospital | Shanghai | Shanghai Municipality | 200031 | 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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Area under the concentration-time curve from time 0 to infinity after SHR-1905 administration
| Start of Treatment to end of study (approximately 16 weeks) |
| Pharmacokinetics-Tmax | Time to Cmax of SHR-1905 | Start of Treatment to end of study (approximately 16 weeks) |
| Pharmacokinetics-Cmax | Maximum observed concentration of SHR-1905 | Start of Treatment to end of study (approximately 16 weeks) |
| Pharmacokinetics-CL/F | Apparent clearance of SHR-1905 | Start of Treatment to end of study (approximately 16 weeks) |
| Pharmacokinetics-V/F | Apparent volume of distribution during terminal phase of SHR-1905 | Start of Treament to end of study (approximately 16 weeks) |
| Pharmacokinetics-t1/2 | Terminal elimination half-life of SHR-1905 | Start of Treatment to end of study (approximately 16 weeks) |
| Anti-Drug antibody | The percentage of subjects with positive ADA titers over time for SHR-1905 | Start of Treatment to end of study (approximately 16 weeks) |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |