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The study is being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of a single-dose subcutaneous injection of SHR-3045 in healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR-3045 Group | Experimental |
| |
| SHR-3045 Placebo Group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-3045 Injection | Drug | SHR-3045 injection. |
| |
| SHR-3045 Placebo Injection |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events (AEs) | From screening period up to Day 113. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration-time curve from time 0 to the last time point after SHR-3045 administration (AUC0-last). | Post-dose at Day 1 to Day 113. | |
| Area under the concentration-time curve from time 0 to infinity after SHR-3045 administration (AUC0-inf). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Frist Affiliated Hospital of USTC (Anhui Provincial Hospital) | Hefei | Anhui | 230001 | China |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Drug |
SHR-3045 placebo injection. |
|
| Post-dose at Day 1 to Day 113. |
| Maximum observed concentration of SHR-3045 (Cmax). | Post-dose at Day 1 to Day 113. |
| Time to maximum observed concentration of SHR-3045 (Tmax). | Post-dose at Day 1 to Day 113. |
| Apparent clearance of SHR-3045 (CL/F). | Post-dose at Day 1 to Day 113. |
| Apparent volume of distribution of SHR-3045 (Vz/F). | Post-dose at Day 1 to Day 113. |
| Terminal elimination half-life of SHR-3045 (t1/2). | Post-dose at Day 1 to Day 113. |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |