Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) Patients
Study Details
Study Description
Brief Summary
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SHR0302 Multiple ascending doses (2, 5, 10, 25 mg), oral tablets |
Drug: SHR0302
Oral tablets (1 mg, 5 mg, 10 mg)
|
| Placebo Comparator: SHR0302 placebo comparator Multiple ascending doses (2, 5, 10, 25 mg), oral tablets (matching corresponding study medication) |
Drug: SHR0302 placebo comparator
Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)
|
Outcome Measures
Primary Outcome Measures
- Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability. [up to 48 hrs postdose]
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
Secondary Outcome Measures
- The maximum plasma concentration (Cmax) of SHR0302 [At protocol-specified times up to 48 hrs postdose]
Blood samples are taken on various timepoints to assess the pharmacokinetic parameters
- The area under the plasma concentration-time curve (AUC) of SHR0302 [At protocol-specified times up to 48 hrs postdose]
- t1/2 of SHR0302 [At protocol-specified times up to 48 hrs postdose]
Other Outcome Measures
- Pharmacodynamics (PD) parameters of percent and actual change from baseline for a panel of JAK dependent biomarkers [At protocol-specified times up to 24 hrs postdose]
To characterize the effects of SHR0302 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - in RA.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female subjects who are 18~70 years of age on the day of signing informed consent,
-
Have a diagnosis of RA meeting the 1987 ACR/EULAR criteria of RA and ACR functional class I-III,
-
Body mass index (BMI = weight/height squared (kg/m2)) within the range of 19 to 30,
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Have agreed to not use any anti- rheumatic drug except for study drugs during the study period.
Exclusion Criteria:
-
Current therapy with any disease modifying anti-rheumatic drug (DMARD), with the exception of Methotrexate (MTX), Leflunomide, sulfasalazine, antimalarials, gold preparations, penicillamine, which must have discontinued for a period of at least 7 t1/2s prior to dosing,
-
Previous RA treatment with DMARDs or drugs with strong immunosuppressive effect in 3 months prior to dosing (12 months for rituximab or other B cell depleting agents),
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Previous therapy with NSAIDs or oral glucocorticoids in 2 weeks before dosing,
-
Any parenteral (intramuscular or intravenous injection) or intra-articular corticosteroids therapy in 4 weeks before dosing,
-
Previous treatment with interferons in 4 weeks before dosing.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | China | 100032 |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
- Principal Investigator: Pei Hu, PhD, Peking Union Medical College Hospital
- Principal Investigator: Xiaofeng Zeng, MD, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR0302-102