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

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR0302
SHR0302 placebo comparator
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SHR0302

SHR0302 placebo comparator

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The maximum plasma concentration (Cmax) of SHR0302
Blood samples are taken on various timepoints to assess the pharmacokinetic parameters
The area under the plasma concentration-time curve (AUC) of SHR0302
t1/2 of SHR0302

Full Information

First Posted
January 24, 2016
Last Updated
April 18, 2016
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02665910
Brief Title
Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) Patients
Official Title
A Phase I, Randomized, Placebo-Controlled, Multiple Doses Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Patients With RA
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SHR0302
Arm Type
Experimental
Arm Description
Multiple ascending doses (2, 5, 10, 25 mg), oral tablets
Arm Title
SHR0302 placebo comparator
Arm Type
Placebo Comparator
Arm Description
Multiple ascending doses (2, 5, 10, 25 mg), oral tablets (matching corresponding study medication)
Intervention Type
Drug
Intervention Name(s)
SHR0302
Intervention Description
Oral tablets (1 mg, 5 mg, 10 mg)
Intervention Type
Drug
Intervention Name(s)
SHR0302 placebo comparator
Intervention Description
Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)
Primary Outcome Measure Information:
Title
Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability.
Description
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
Time Frame
up to 48 hrs postdose
Secondary Outcome Measure Information:
Title
The maximum plasma concentration (Cmax) of SHR0302
Description
Blood samples are taken on various timepoints to assess the pharmacokinetic parameters
Time Frame
At protocol-specified times up to 48 hrs postdose
Title
The area under the plasma concentration-time curve (AUC) of SHR0302
Time Frame
At protocol-specified times up to 48 hrs postdose
Title
t1/2 of SHR0302
Time Frame
At protocol-specified times up to 48 hrs postdose
Other Pre-specified Outcome Measures:
Title
Pharmacodynamics (PD) parameters of percent and actual change from baseline for a panel of JAK dependent biomarkers
Description
To characterize the effects of SHR0302 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - in RA.
Time Frame
At protocol-specified times up to 24 hrs postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chengyu Guan, MD
Phone
15705155015
Email
guanchengyu@hrs.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pei Hu, PhD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zeng, MD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pei Hu, PhD
Phone
86-010-69158366
Email
pei.hu.pumc@gmail.com
First Name & Middle Initial & Last Name & Degree
Pei Hu, PhD
First Name & Middle Initial & Last Name & Degree
Xiaofeng Zeng, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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