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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
64
Oral tablets (1 mg, 5 mg, 10 mg)
Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)
First Affiliated Hospital of Fourth Military Medical University
Xi’an, Shanxi, 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 72 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 72 hrs postdose
The area under the plasma concentration-time curve (AUC) of SHR0302
Time frame: At protocol-specified times up to 72 hrs postdose
t1/2 of SHR0302
Time frame: At protocol-specified times up to 72 hrs postdose
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.
Time frame: At protocol-specified times up to 24 hrs postdose
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