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Condition: Rheumatoid Arthritis Intervention: Drug: SHR0302; Drug: SHR0302 placebo comparator Phase: Phase 1 Study Type: Interventional Study Design: Treatment, Parallel Assignment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Randomized
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR0302 | Experimental | Multiple ascending doses (2, 5, 10, 25 mg), oral tablets |
|
| SHR0302 placebo comparator | Placebo Comparator | Multiple ascending doses (2, 5, 10, 25 mg), oral tablets (matching corresponding study medication) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR0302 | Drug | Oral tablets (1 mg, 5 mg, 10 mg) |
| |
| SHR0302 placebo comparator |
| 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 48 hrs postdose |
| Measure | Description | Time Frame |
|---|---|---|
| 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 48 hrs postdose |
| The area under the plasma concentration-time curve (AUC) of SHR0302 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 RA. | At protocol-specified times up to 24 hrs postdose |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengyu Guan, MD | Contact | 15705155015 | guanchengyu@hrs.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Pei Hu, PhD | Peking Union Medical College Hospital | Principal Investigator |
| Xiaofeng Zeng, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | 100032 | 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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| Drug |
Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication) |
|
| At protocol-specified times up to 48 hrs postdose |
| t1/2 of SHR0302 | At protocol-specified times up to 48 hrs postdose |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |