Back to resultsFirst-in-Human Single Ascending Dose of SHR0302
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR0302
SHR0302 placebo comparator
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Healthy subjects, age 18-45 years (inclusive);
- The weight of the subject should be more than 50 kg, body mass index (BMI = weight/height squared (kg/m2)) within the range of 19 to 24.
Exclusion Criteria:
- Any condition that might interfere with the procedures or tests in the study
- History of heart failure or renal insufficiency
- Smoking; Drug or alcohol abuse
Sites / Locations
- First Affiliated Hospital of Fourth Military Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
single ascending doses
Placebo
Arm Description
single ascending doses, oral tablets
Placebo Comparator, oral tablets
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.
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
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 healthy volunteers.
Secondary Outcome Measures
Full Information
NCT ID
NCT02423538
First Posted
April 7, 2015
Last Updated
January 24, 2016
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02423538
Brief Title
First-in-Human Single Ascending Dose of SHR0302
Official Title
A Phase I, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2015 (undefined)
Primary Completion Date
July 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
The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral doses of SHR0302 compared to placebo. Also, pharmacokinetics (PK) and pharmacodynamics (PD) of SHR0302 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined.
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
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single ascending doses
Arm Type
Experimental
Arm Description
single ascending doses, oral tablets
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator, oral tablets
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 72 hrs postdose
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 72 hrs postdose
Title
The area under the plasma concentration-time curve (AUC) of SHR0302
Time Frame
At protocol-specified times up to 72 hrs postdose
Title
t1/2 of SHR0302
Time Frame
At protocol-specified times up to 72 hrs postdose
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 healthy volunteers.
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
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy subjects, age 18-45 years (inclusive);
The weight of the subject should be more than 50 kg, body mass index (BMI = weight/height squared (kg/m2)) within the range of 19 to 24.
Exclusion Criteria:
Any condition that might interfere with the procedures or tests in the study
History of heart failure or renal insufficiency
Smoking; Drug or alcohol abuse
Facility Information:
Facility Name
First Affiliated Hospital of Fourth Military Medical University
City
Xi'an
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
12. IPD Sharing Statement
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First-in-Human Single Ascending Dose of SHR0302
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