First-in-Human Single Ascending Dose of SHR0302

Study Overview
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Brief Summary
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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.

Official 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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: SHR0302
* Drug: SHR0302 placebo comparator


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single ascending doses<br>single ascending doses, oral tablets | Drug: SHR0302<br>* Oral tablets (1 mg, 5 mg, 10 mg)<br>|
| Placebo Comparator: Placebo<br>Placebo Comparator, oral tablets | Drug: SHR0302 placebo comparator<br>* Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | up to 72 hrs postdose | 
| The maximum plasma concentration (Cmax) of SHR0302 | Blood samples are taken on various timepoints to assess the pharmacokinetic parameters | At protocol-specified times up to 72 hrs postdose | 
| 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 | To characterize the effects of SHR0302 on mechanism of action-related biomarkers in the blood over time - pharmacodynamics (PD) - in healthy volunteers. | At protocol-specified times up to 24 hrs postdose |