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The purpose of this study is to assess safety, PK, Pharmacodynamic and immunogenicity profile of a single dose of SHR-2173 in healthy participants
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-2173 single dose | Experimental | Single dose of SHR-2173/ given subcutaneously |
|
| SHR-2173 placebo single dose | Experimental | Single dose of SHR-2173/placebo given subcutaneously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-2173 Injection/SHR-2173 placebo | Drug | Single dose SHR-2173 injection or matching placebo given subcutaneously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics - Cmax | Maximum observed plasma concentration (Cmax) | Day 71 |
| Pharmacokinetics - AUCâ‚€-t | Area under the plasma concentration-time curve from time 0 to the last measurable concentration (AUCâ‚€-t) | Day 71 |
| Pharmacokinetics - AUCâ‚€-inf | Area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCâ‚€-inf) | Day 71 |
| Pharmacokinetics - Tmax | Time to reach maximum observed plasma concentration (Tmax) | Day 71 |
| Pharmacokinetics - t½ | Terminal elimination half-life (t½) | Day 71 |
| Immunogenicity - Anti-Drug Antibody (ADA) | Incidence and onset time of anti-drug antibody (ADA) | Day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events | Number of participants with Adverse events and Serious adverse events | Day 71 |
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Main inclusion criteria
Main exclusion Criteria
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veritus Research | Melbourne | Victoria | Australia |
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Single dose of SHR-2173 will be administered subcutaneously
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