A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of JX2105 in Healthy Chinese Subjects

Exclusion Criteria

• •1. Having a history or present condition of diseases or dysfunction that may affect the clinical trial on the consideration of investigator, including but not limited to central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, blood system and other diseases;
• •2. Having a history or present condition of mental illness;
• •3. Any surgical condition or condition that could significantly affect the absorption, distribution, metabolism, and excretion of the investigational drug or could jeopardize the subjects participating in the trial; such as a history of gastrointestinal surgery (gastrectomy, gastrointestinal anastomosis, intestinal resection, etc.), urinary tract obstruction or dysuria, gastroenteritis, gastrointestinal ulcer, gastrointestinal bleeding, etc.;
• •4. Usage of any drugs within 2 weeks before screening, including prescription drugs, over-the-counter drugs and Chinese herbal medicines;
• •5. With a known history of allergy to investigational drug ingredients or similar drugs, history of allergic diseases or allergic constitution;
• •6. Having clinical significance in laboratory test in the opinion of the Investigator, or creatinine clearance \< 80 mL/min;
• •7. Having clinical significant electrocardiogram (ECG) abnormality and chest X-ray examination indicators, in the opinion of the Investigator;
• •8. Having clinical significance in vital signs, with sitting resting pulse rate \< 50 beats/min or \> 100 beats/min; systolic blood pressure \< 90 mmHg or \> 140 mmHg; diastolic blood pressure \< 50 mmHg or \> 90 mmHg, in the opinion of the Investigator;
• •9. Having one or more clinically significant tests for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus antibody and treponema pallidum antibody;
• •10. Female participant with positive pregnancy test results;
• •11. History of drug or drug abuse within 1 year before screening, or positive urine drug screening;
• •12. Alcohol abuse within 1 year before screening, with an average weekly alcohol intake of more than 14 units or positive alcohol breath test;
• •13. With average daily smoking ≥ 5 cigarettes within 3 months before screening;
• •14. With no suitable veins for multiple venipuncture/catheterization as assessed at screening;
• •15. Having blood donation (including blood component donation) or massive blood loss (≥ 200 mL) within 3 months before screening; or receive blood transfusion or using blood products;
• •16. Having a history of surgery within 3 months before screening, or has not recovered from surgery, or will have a scheduled surgery during the study.