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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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1 February 2016 |
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Main ID: |
NCT02423538 |
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Date of registration:
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07/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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First-in-Human Single Ascending Dose of SHR0302
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Scientific title:
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A Phase I, Randomized, Placebo-Controlled, Single Dose Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Healthy Volunteers |
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Date of first enrolment:
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April 2015 |
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Target sample size:
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64 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02423538 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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China
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: SHR0302
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Drug: SHR0302 placebo comparator
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Primary Outcome(s)
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t1/2 of SHR0302
[Time Frame: At protocol-specified times up to 72 hrs postdose]
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Pharmacodynamics (PD)parameters of percent and actual change from baseline for a panel of JAK-dependent biomarkers
[Time Frame: At protocol-specified times up to 24 hrs postdose]
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Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability.
[Time Frame: up to 72 hrs postdose]
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The maximum plasma concentration (Cmax) of SHR0302
[Time Frame: At protocol-specified times up to 72 hrs postdose]
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The area under the plasma concentration-time curve (AUC) of SHR0302
[Time Frame: At protocol-specified times up to 72 hrs postdose]
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Secondary ID(s)
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SHR0302-101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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