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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
Oral tablets (1 mg, 5 mg, 10 mg)
Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)
Peking Union Medical College Hospital
Beijing, China
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
Time frame: up to 48 hrs postdose
The maximum plasma concentration (Cmax) of SHR0302
Blood samples are taken on various timepoints to assess the pharmacokinetic parameters
Time frame: At protocol-specified times up to 48 hrs postdose
The area under the plasma concentration-time curve (AUC) of SHR0302
Time frame: At protocol-specified times up to 48 hrs postdose
t1/2 of SHR0302
Time frame: At protocol-specified times up to 48 hrs postdose
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