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This is a single center, randomized, double-blind, placebo-controlled, single and multiple dose escalation phase 1 study. The objective of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneous administered SHR-1819 in healthy subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group A | Experimental |
| |
| Treatment group B | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1819 | Drug | SHR-1819 will be subcutaneously administered with different dose levels; |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence and severity of adverse events | Start of Treatment to end of study(about 13 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics-AUC0-last | Area under the concentration-time curve from time 0 to last time point after SHR-1819 administration | Start of Treatment to end of study (about 13 weeks) |
| Pharmacokinetics-AUC0-inf |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Third Xiangya Hospital of Central South University | Changsha | Changsha | 410013 | 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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Parallel Assignment
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| Placebo | Drug | Placebo will be subcutaneously administered with different dose levels; |
|
Area under the concentration-time curve from time 0 to infinity after SHR-1819 administration
| Start of Treatment to end of study (approximately 13 weeks) |
| Pharmacokinetics-Tmax | Time to Cmax of SHR-1819 | Up to 13 weeks |
| Pharmacokinetics-Cmax | Maximum observed concentration of SHR-1819 | Up to 13 weeks |
| Pharmacokinetics-CL/F | Apparent clearance of SHR-1819 | Up to 13 weeks |
| Pharmacokinetics-Vz/F | Apparent volume of distribution during terminal phase of SHR-1819 | Up to 13 weeks |
| Pharmacokinetics-t1/2 | Terminal elimination half-life of SHR-1819 | Up to 13 weeks |
| Change from baseline to end of treatment for Thymus and activation-regulated chemokine(TARC/CCL17) | Thymus and activation-regulated chemokine(TARC/CCL17) | Up to 13 weeks |
| Change from baseline to end of treatment for IgE | IgE | Up to 13 weeks |
| Immunogenicy of SHR-1819 after administration | Anti-drug antibody | Up to 13 weeks] |
| Pharmacokinetics-AUCtau for multi-dose | Area under the concentration-time curve from time 0 to last time point after SHR-1819 administration | Start of Treatment to end of study (about 13 weeks) |
| Pharmacokinetics- Ctrough for multi-dose | Minimum observed concentration of SHR-1819 | Up to 13 weeks |
| Pharmacokinetics- Racc for multi-dose | Accumulation ratio of SHR-1819 | Up to 13 weeks |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |