Rheumatoid Arthritis
Conditions
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.
Interventions
DRUGSHR0302
Oral tablets (1 mg, 5 mg, 10 mg)
Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability. | up to 72 hrs postdose | 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 | At protocol-specified times up to 72 hrs postdose | Blood samples are taken on various timepoints to assess the pharmacokinetic parameters |
| The area under the plasma concentration-time curve (AUC) of SHR0302 | At protocol-specified times up to 72 hrs postdose | — |
| t1/2 of SHR0302 | 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 | At protocol-specified times up to 24 hrs postdose | To characterize the effects of SHR0302 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - in healthy volunteers. |
Countries
China
Outcome results
None listed