Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) Patients

Study Overview
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Brief Summary
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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

Official Title
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A Phase I, Randomized, Placebo-Controlled, Multiple Doses Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Patients With RA

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: SHR0302
* Drug: SHR0302 placebo comparator


Participation Criteria
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Eligibility Criteria
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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, 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), 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SHR0302<br>Multiple ascending doses (2, 5, 10, 25 mg), oral tablets | Drug: SHR0302<br>* Oral tablets (1 mg, 5 mg, 10 mg)<br>|
| Placebo Comparator: SHR0302 placebo comparator<br>Multiple ascending doses (2, 5, 10, 25 mg), oral tablets (matching corresponding study medication) | Drug: SHR0302 placebo comparator<br>* Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | At protocol-specified times up to 48 hrs postdose | 
| t1/2 of SHR0302 |  | At protocol-specified times up to 48 hrs postdose |