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The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral doses of SHR0302 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of SHR0302 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single ascending doses | Experimental | single ascending doses, oral tablets |
|
| Placebo | Placebo Comparator | Placebo Comparator, oral tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0302 | Drug | Oral tablets (1 mg, 5 mg, 10 mg) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability. | Tests will be performed to assess whether the study drug has any potentially adverse effect (laboratory tests on blood and urine for functioning of organs; cardiovascular testing, i.e. of heart and blood circulation). Also, participants will carefully be monitored by medical staff for vital signs, and asked to report any side effect experienced in the course of the study. | up to 72 hrs postdose |
| The maximum plasma concentration (Cmax) of SHR0302 | Blood samples are taken on various timepoints to assess the pharmacokinetic parameters | At protocol-specified times up to 72 hrs postdose |
| The area under the plasma concentration-time curve (AUC) of SHR0302 | At protocol-specified times up to 72 hrs postdose | |
| t1/2 of SHR0302 | At protocol-specified times up to 72 hrs postdose | |
| Pharmacodynamics (PD)parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers | To characterize the effects of SHR0302 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - in healthy volunteers. | At protocol-specified times up to 24 hrs postdose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Fourth Military Medical University | Xi’an | Shanxi | 710032 | 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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| ID | Term |
|---|---|
| C000615713 | ivarmacitinib |
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| SHR0302 placebo comparator |
| Drug |
Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication) |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |