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

NCT02665910 | Unknown Phase 1

• 1 other identifier: SHR0302-102
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The maximum plasma concentration (Cmax) of SHR0302

  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

Other Outcomes (1)

• 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

Study Arms (2)

SHR0302

EXPERIMENTAL

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

Drug: SHR0302

SHR0302 placebo comparator

PLACEBO COMPARATOR

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

Drug: SHR0302 placebo comparator

Interventions

SHR0302 DRUG

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

SHR0302

SHR0302 placebo comparator DRUG

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

SHR0302 placebo comparator

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100032, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ivarmacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pei Hu, PhD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Xiaofeng Zeng, MD

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chengyu Guan, MD

CONTACT

15705155015; guanchengyu@hrs.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2016
• First Posted: January 28, 2016
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Last Updated: April 19, 2016

Record last verified: 2016-01

Locations

CN (1)