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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02665910
• Other study ID #: SHR0302-102
• Status: Not yet recruiting
• Phase: Phase 1
• First received: January 24, 2016
• Last updated: April 18, 2016
• Start date: May 2016

Study information

• Verified date: January 2016
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: Chengyu Guan, MD
• Phone: 15705155015
• Email: guanchengyu[@]hrs.com.cn
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• SHR0302
Oral tablets (1 mg, 5 mg, 10 mg)
• SHR0302 placebo comparator
Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	Yes
Secondary	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	No
Secondary	The area under the plasma concentration-time curve (AUC) of SHR0302		At protocol-specified times up to 48 hrs postdose	No
Secondary	t1/2 of SHR0302		At protocol-specified times up to 48 hrs postdose	No