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

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

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

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: SHR0302; Drug: SHR0302 placebo comparator

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Chengyu Guan, MD; Phone Number: 15705155015; Email: guanchengyu@hrs.com.cn

Study Locations

• China
  • Beijing, China, 100032
    • Peking Union Medical College Hospital
    • Contact: Pei Hu, PhD; Phone Number: 86-010-69158366; Email: pei.hu.pumc@gmail.com
    • Principal Investigator: Pei Hu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SHR0302; Multiple ascending doses (2, 5, 10, 25 mg), oral tablets	Drug: SHR0302; Oral tablets (1 mg, 5 mg, 10 mg)
PLACEBO_COMPARATOR: SHR0302 placebo comparator; Multiple ascending doses (2, 5, 10, 25 mg), oral tablets (matching corresponding study medication)	Drug: SHR0302 placebo comparator; Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Pei Hu, PhD, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: January 24, 2016
• First Submitted That Met QC Criteria: January 24, 2016
• First Posted (ESTIMATE): January 28, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): April 19, 2016
• Last Update Submitted That Met QC Criteria: April 18, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: SHR0302-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED