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

Phase 1

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: SHR0302 placebo comparator; Drug: SHR0302

• Registration Number: NCT02665910
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-01
• Study First Submitted: 2016-01-24
• Study First Submitted QC: 2016-01-24
• Study First Posted: 2016-01-28
• Last Update Submitted: 2016-04-18
• Last Update Posted: 2016-04-19
• Study Start: 2016-05
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SHR0302 placebo comparator	SHR0302 placebo comparator	Multiple ascending doses (2, 5, 10, 25 mg), oral tablets (matching corresponding study medication)
SHR0302	SHR0302	Multiple ascending doses (2, 5, 10, 25 mg), oral tablets

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, China