Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR-3045 in healthy subjects.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai General Hospital | Shanghai | Shanghai Municipality | 200080 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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. |
| Clearance of SHR-3045 (CL). | 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. |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided