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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

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

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SHR0302

Multiple ascending doses (2, 5, 10, 25 mg), oral tablets

Group Type EXPERIMENTAL

SHR0302

Intervention Type DRUG

Oral tablets (1 mg, 5 mg, 10 mg)

SHR0302 placebo comparator

Multiple ascending doses (2, 5, 10, 25 mg), oral tablets (matching corresponding study medication)

Group Type PLACEBO_COMPARATOR

SHR0302 placebo comparator

Intervention Type DRUG

Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)

Interventions

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SHR0302

Oral tablets (1 mg, 5 mg, 10 mg)

Intervention Type DRUG

SHR0302 placebo comparator

Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)

Intervention Type DRUG

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No