| Eligibility |
Inclusion Criteria.
1. No restriction on nationality, age 18-55 years old (including borderline value), no
restriction on gender;
2. Body weight: Male =50kg, female =45kg and 18.5kg/m2=BMI=30kg/m2 (BMI=Body Mass Index
(BMI) = Weight (kg)÷Height (m)2);
3. Blood pressure:
12.0Kpa (90mmHg)=systolic blood pressure=18.7Kpa (140mmHg) 8.0Kpa (60mmHg) = diastolic
blood pressure = 12.0Kpa (90mmHg);
4. Pulse: 60 beats/min = pulse = 100 beats/min, = 50 beats/min for high endurance
athletes, or rhythmic abnormalities without clinical significance;
5. Ear temperature: 35.7 = body temperature = 37.5 ?;
6. Good general condition of the body: no damage to vital organs such as heart, lungs,
liver, kidneys, etc., no serious or uncontrolled infections, no history of serious
mental disorders;
7. Clinical examination should fulfill the following criteria:
7.1 Hemoglobin (Hb) measurement is normal or abnormal without clinical significance; 7.2
White blood cell (WBC) measurement: (3.5-10) × 109/L; 7.3 Platelet count (PLT)
determination normal or abnormal without clinical significance; 7.4 Neutrophil count (NEU)
determination normal or abnormal without clinical significance; 7.5 Normal or abnormal
liver and kidney function test indexes without clinical significance; 7.6 Normal or
abnormal coagulation function without clinical significance; 7.7 Hepatitis B virus surface
antigen (HBsAg) negative; 7.8 Hepatitis C virus antibody (HCV antibody) negative; 7.9 human
immunodeficiency virus antibody (HIV-1 and HIV-2 antibody) negative; 7.10 Syphilis
negative;
Exclusion Criteria.
1. the following diseases considered clinically significant by the investigator: 1.1 Have
respiratory, circulatory, gastrointestinal, urinary, hematologic, immunologic,
endocrine system diseases or metabolic disorders; neurological disorders, psychiatric
disorders, Creutzfeldt-Jakob disease, and those with a family history of the disease,
or those who are receiving treatment with tissues or tissue derivatives that may have
originated from infection with Creutzfeldt-Jakob pathogens; 1.2 Persons with chronic
skin diseases, especially infectious, allergic or inflammatory systemic skin diseases;
persons with allergic diseases or recurrent allergic attacks; 1.3 persons with
malignant tumors or benign tumors affecting health;
2. those who have not completed 3 months of minor surgery, such as appendectomy,
ophthalmic surgery after healing, etc.; those who have not completed 1 year of major
surgery, such as: benign gynecological tumors, gastrointestinal malignant tumors after
surgery, etc;
3. Women during pregnancy, less than 6 months after abortion, and less than 1 year after
delivery and breastfeeding;
4. Less than 1 week after recovering from upper respiratory tract infection or less than
3 months after recovering from pneumonia;
5. less than 3 months after recovery from acute pyelonephritis, or during the period of
urinary stone attack;
6. Injury caused by equipment contaminated by blood or tissue fluid or contaminated
wounds, or less than 1 year after tattooing;
7. Those who have received whole blood and blood component transfusion within 1 year;
8. within 2 weeks after the last vaccination with live attenuated measles, mumps, or
polio vaccine, or within 4 weeks after the last immunization with live rubella vaccine
or live attenuated encephalitis B vaccine;
9. Within 1 year after the last immunization with rabies vaccine after being bitten by an
animal;
10. within 4 weeks of the last immunization with antitoxin or immune serum injection or
within 1 year of the last immunization with hepatitis B human immunoglobulin injection
11. those who have a documented clinical trial with leukocyte, plasma, platelet, or whole
blood donation within 3 months
12. who, in the opinion of the investigator, are not suitable for participation in this
study.
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