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This study is a phase 1 single dose escalation study of SHR-1906 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of SHR-1906 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | A single subcutaneous injection of SHR-1906/placebo dose 1 in healthy subjects |
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| Cohort 2 | Experimental | A single subcutaneous injection of SHR-1906/placebo dose 2 in healthy subjects |
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| Cohort 3 | Experimental | A single subcutaneous injection of SHR-1906/placebo dose 3 in healthy subjects |
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| Cohort 4 | Experimental | A single subcutaneous injection of SHR-1906/placebo dose 4 in healthy subjects |
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| Cohort 5 | Experimental | A single subcutaneous injection of SHR-1906/placebo dose 5 in healthy subjects |
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| Cohort 6 | Experimental | A single subcutaneous injection of SHR-1906/placebo dose 6 in healthy subjects |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1906;Placebo | Drug | Drug: SHR-1906 IV, single dose Drug: Placebo IV, 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 10 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics-AUC0-last | Area under the concentration-time curve from time 0 to last time point after SHR-1906 administration | Start of Treatment to end of study (approximately 10 weeks) |
| Pharmacokinetics-AUC0-inf |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phase I Clinical Research Unit, Qianfoshan Hospital of Shandong Province | Jinan | Shandong | 250014 | China |
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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SHR-1906 compared with placebo
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Area under the concentration-time curve from time 0 to infinity after SHR-1906 administration
| Start of Treatment to end of study (approximately 10 weeks) |
| Pharmacokinetics-Tmax | Time to Cmax of SHR-1906 | Start of Treatment to end of study (approximately 10 weeks) |
| Pharmacokinetics-Cmax | Maximum observed concentration of SHR-1906 | Start of Treatment to end of study (approximately 10 weeks) |
| Pharmacokinetics-CL | Clearance of SHR-1906 | Start of Treatment to end of study (approximately 10 weeks) |
| Pharmacokinetics-V | Volume of distribution during terminal phase of SHR-1906 | Start of Treatment to end of study (approximately 10 weeks) |
| Pharmacokinetics-t1/2 | Terminal elimination half-life of SHR-1906 | Start of Treatment to end of study (approximately 10 weeks) |
| Anti-Drug antibody | The percentage of subjects with positive ADA titers over time for SHR-1906 | Start of Treatment to end of study (approximately 10 weeks) |