| Eligibility |
Inclusion Criteria:
- Subjects can be enrolled only when they meet all the following inclusion criteria:
1. Signed the informed consent form prior to the study, sufficient understanding of
the content, procedure and possible adverse reactions of the study;
2. Willing and able to comply with the visit and treatment specified in the study;
3. Subjects (including their partners) who are willing to refrain from pregnancy,
sperm donation and take effective contraceptive method in the future 6 months
(i.e., 6 months after study medication), see Appendix 4 for the detailed
contraceptive measures;
4. Healthy male subjects aged 18~55 years (inclusive);
5. BMI ranging from 18.0~28.0 kg/m2 (inclusive), and weight ranging from 55.0~85.0
kg (inclusive);
6. Normal or abnormal physical examination that is judged as clinically
insignificant;
Exclusion Criteria:
- Subjects can not be enrolled in this study if any of the following criteria is met:
1. Smoking >5 cigarettes per day within three months prior to the study;
2. Any serious allergic reaction to food or drug at present or in the past, or
allergy to Tocilizumab, or serious allergy or allergic reaction to human,
humanized or murine monoclonal antibody;
3. History of excessive drinking (14 units of alcohol per week: 1 unit = 285 mL
beer, or 25 mL liquor, or 125 mL wine);
4. Blood donation or massive blood loss (>450 mL) within three months prior to
screening, or plan for blood donation or surgery during the study;
5. Intake of any prescription drug, over-the-counter drug, any vitamin product or
herbal medicine within 28 days prior to screening;
6. Great change in dietary or exercise habit within 2 weeks prior to screening or
from screening to administration;
7. Having any disease that may increase hemorrhagic risk, such as haemorrhoids with
hemorrhagic symptoms, acute gastritis or gastric and duodenal ulcer;
8. Clinically significant abnormality in echocardiography;
9. Clinically significant abnormality in clinical laboratory examination, or other
clinical findings showing the following disorders of clinical relevance
(including but not limited to gastrointestinal, renal, hepatic, neurological,
hematological, endocrine, oncological, pulmonary, immune, mental or cerebro- and
cardiovascular diseases);
10. Clinically significant (judged by investigators) abnormality in ECG, or QTcF >
450ms (allowed to be repeated for once, the subject needs to be excluded if the
two measurements of QTcF are > 450ms);
11. Acute disease or concomitant medication from screening to prior to administration
of study drug;
12. Positive urine drug screen, or history of drug abuse or use of narcotics in the
past 5 years;
13. Positive HBsAg in five hepatitis B markers at screening; or positive anti-HBc and
negative anti-HBs; or positive hepatitis C antibody; or positive HIV antibody; or
positive Treponema pallidum antibody;
14. Intake of any alcohol-containing product within 48 hours prior to dosing of study
drug, or failure to limit alcohol consumption as required during the study;
15. Currently or previously having malignant tumor;
16. History of hypertension, or systolic blood pressure = 140 mmHg, or diastolic
blood pressure =90 mmHg at screening/baseline (allowed to be repeated for once,
the subject needs to be excluded if the two measurements of systolic blood
pressure = 140 mmHg, or diastolic blood pressure =90 mmHg);
17. Patients with hepatic disorder who are judged by investigators as inappropriate
for enrollment;
18. Presence of active infection, including acute and chronic infection as well as
local infection;
19. Chest X-ray showing active pulmonary tuberculosis; or previous history of
tuberculosis or latent tuberculosis infection, or clinical manifestations
suspected as tuberculosis (including but not limited to pulmonary tuberculosis);
Positive for T-SPOT®.TB interferon-?-release assays, or contact with patients
with tuberculosis within three months or/and symptoms or/and signs suspected as
tuberculosis;
20. Had received or plan to receive live virus vaccine or immunosuppressant within 12
weeks prior to administration of study drug;
21. Having participated in drug clinical trial within three months prior to the first
dose of study drug, or plan to participate in other drug clinical trial during
the study;
22. Those who are considered by investigators as inappropriate for enrollment.
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