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 main purpose of this study is to evaluate the safety, Tolerability and Pharmacokinetics (PK) of SHR1314 with axial spondyloarthritis.
This was a phase I, multicenter, double-blind, randomized, placebo-controlled study. The study originally planned to enroll 5 cohorts of 8 subjects each (N=40).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Multiple subcutaneous injections of SHR-1314 dose 1 |
|
| Cohort 2 | Experimental | Multiple subcutaneous injections of SHR-1314 dose 2 |
|
| Cohort 3 | Experimental | Multiple subcutaneous injections of SHR-1314 dose 3 |
|
| Cohort 4 | Experimental | Multiple subcutaneous injections of SHR-1314 dose 4 |
|
| Cohort 5 | Experimental | Multiple subcutaneous injections of SHR-1314 dose 5 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR-1314 | Drug | Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The safety and tolerability of multiple subcutaneous injections of SHR1314 in adult patients with axial spondyloarthritis 1.Incidence of Treatment-Emergent Adverse Events 2.Incidence of Injection site reaction | Safety and tolerability of multiple subcutaneous injections of SHR1314 assessed by adverse events and serious adverse events.
| Baseline to 169 days after dose administration |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum observed serum concentration (Cmax) of SHR-1314 | maximum concentration (Cmax) | Baseline to 169 days after dose administration |
| Time to maximum observed serum concentration (tmax) of SHR-1314 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fei Sun, MD | People's Liberation Army General Hospital | Principal Investigator |
| Xin Chang, MD | The First Affiliated Hospital of Soochow University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jianwen Chen | Shanghai | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Time to maximum concentration (Tmax)
| Baseline to 169 days after dose administration |
| Time to elimination half-life (t1/2) of SHR-1314 | t1/2 | Baseline to 169 days after dose administration |
| Assessment of development of Anti-drug Antibodies (ADAs) | Incidence of development of Anti-drug Antibodies (ADAs) | Baseline to 169 days after dose administration |
| Proportion of Participants Achieving an ASAS20 Response | ASAS20 Response | Week2, 4, 6, 8, 12,16 |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |