| Eligibility |
Inclusion Criteria:
1. Voluntary signing of informed consent form before related activities of the experiment
and understanding of the procedures and methods of the experiment, willing to strictly
follow the clinical trial protocol to complete the experiment.
2. Both men and women are eligible, aged 18 to 45 years old (inclusive, as determined at
the time of signing informed consent form).
3. Body mass index (BMI) is between 18 and 25 kg/m2 (inclusive), with male weight = 50 kg
and female weight = 45 kg.
4. Subjects with normal physical examination results and with normal laboratory results
(blood, chemistry, urine, drug screening, coagulation function test), ECG and X-ray
chest test are normal or with certain abnormal without clinical significance.
Exclusion Criteria:
1. Having a history of any clinically significant disease or condition that the
investigator believes may affect the trial results, including but not limited to a
history of cardiovascular, endocrine, neurological, digestive, urinary, hematological,
immunological, metabolic diseases, or existing diseases in these systems.
2. Have a history of drug or other allergies, or are likely to be allergic to the
investigational drug or any component of the investigational drug as determined by the
investigator.
3. History or current infection with human immunodeficiency virus (HIV) or hepatitis C;
or current hepatitis B infection or syphilis.
4. History of lymphoproliferative disease or any known malignancy or history of
malignancy of any organ system within the past 5 years.
5. History of chronic or recurrent infectious disease, or evidence of active or latent
tuberculosis infection.
6. Clinical symptoms, signs, laboratory tests, or X-rays suggest active or latent
tuberculosis Tuberculosis infected persons;
7. Those who have participated in any clinical study for any drug or medical device
within 3 months before screening
8. Those who have received live attenuated vaccine within 12 weeks prior to screening or
plan to receive live attenuated vaccine during the trial.
9. Blood donation or blood loss = 400 mL within 8 weeks prior to screening, or receiving
blood transfusion within 8 weeks;
10. Venous blood collection difficulties or physical conditions can not withstand blood
collection;
11. Had used other drugs (including prescription drugs, over-the-counter drugs, Chinese
herbal medicines and dietary supplements) in the 2 weeks before screening;
12. Current or past alcoholics (drinking more than 14 standard units per week) 1 Standard
unit containing 14g of alcohol, such as 360 mL beer or 45 mL spirits with 40% alcohol
or 150 mL wine); Or who cannot abstain from alcohol during the trial;
13. The average daily smoking amount in the 3 months before the test was = 10 cigarettes;
Or cannot stop using any tobacco products during the trial
14. History or evidence of ongoing alcohol or drug abuse, within the last six months
before Baseline.
15. Female and male subjects who are fertile (defined as having the physical conditions
necessary to become pregnant) who plan to become pregnant or donate sperm/egg within
20 weeks of using the study drug (greater than 5 half-lives) or who do not wish to use
contraception; Female subjects who are fertile but have not used contraception in the
30 days prior to randomization;
16. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
female after conception and until the termination of gestation, confirmed by a
positive hCG laboratory test.
17. Subjects judged by the investigator as unsuitable for participating in this study.
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