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This study is a phase 1 single dose or multiple doses escalation study of SHR-2001 in healthy subjects. The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-2001 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | A single subcutaneous injection of SHR-2001/placebo dose 1 in healthy subjects. |
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| Cohort 2 | Experimental | A single subcutaneous injection of SHR-2001/placebo dose 2 in healthy subjects. |
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| Cohort 3 | Experimental | A single subcutaneous injection of SHR-2001/placebo dose 3 in healthy subjects. |
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| Cohort 4 | Experimental | A single subcutaneous injection of SHR-2001/placebo dose 4 in healthy subjects. |
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| Cohort 5 | Experimental | A single subcutaneous injection of SHR-2001/placebo dose 5 in healthy subjects. |
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| Cohort 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2001 | Drug | Subcutaneous injection, single dose or multiple doses. |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Incidence and severity of adverse events | Start of Treatment to end of study (approximately 64 days). |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics-AUC0-t | Area under the concentration-time curve from 0 to the last measurable time point after SHR-2001 administration | Start of Treatment to end of study (approximately 64 days). |
| Pharmacokinetics-AUC0-inf |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Qingdao University | Qingdao | Shandong | 266000 | China |
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A single subcutaneous injection of SHR-2001/placebo dose 6 in healthy subjects. |
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| Cohort 7 | Experimental | A single subcutaneous injection of SHR-2001/placebo dose 7 in healthy subjects. |
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| Cohort 8 | Experimental | A single subcutaneous injection of SHR-2001 / placebo dose 8 in healthy subjects. |
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| Cohort 9 | Experimental | A single subcutaneous injection of SHR-2001 / placebo dose 9 in healthy subjects. |
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| Cohort 10 | Experimental | A single subcutaneous injection of SHR-2001 / placebo dose 10 in healthy subjects. |
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| Cohort 11 | Experimental | A multiple subcutaneous injection of SHR-2001 / placebo dose 11 in healthy subjects. |
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| Cohort 12 | Experimental | A multiple subcutaneous injection of SHR-2001 / placebo dose 12 in healthy subjects. |
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| Placebo | Drug | Subcutaneous injection, single dose or multiple doses. |
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Area under the concentration-time curve from time 0 to infinity after SHR-2001 administration
| Start of Treatment to end of study (approximately 64 days). |
| Pharmacokinetics-Cmax | Maximum observed concentration of SHR-2001 | Start of Treatment to end of study (approximately 64 days). |
| Pharmacokinetics-Tmax | Time to Cmax | Start of Treatment to end of study (approximately 64 days). |
| Pharmacokinetics-t1/2 | Terminal elimination half-life of SHR-2001 | Start of Treatment to end of study (approximately 64 days). |
| Pharmacokinetics-CL/F | Apparent clearance of SHR-2001 | Start of Treatment to end of study (approximately 64 days). |
| Pharmacokinetics-Vz/F | Apparent volume of distribution during terminal phase of SHR-2001 | Start of Treatment to end of study (approximately 64 days). |
| Anti-Drug antibody | The percentage of subjects with positive ADA | Start of Treatment to end of study (approximately 64 days). |