Rheumatoid arthritis
Conditions
Interventions
Group1:BAT1806 subcutaneous injection group
Group2:ACTEMRA (EU) group
Sponsors
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Those who have signed an informed consent form before the trial and are fully understand the content, procedure and possible adverse effects of the trial; 2. Those who are willing and able to follow the visits and treatment prescribed in the study; 3. The subject (including partner) is willing to have no plans to become pregnant or to donate sperm within the next 6 months (within 6 months after drug administration) and to use effective contraception, as described in Appendix 4; 4. Healthy male subjects aged between 18 and 55 years (including upper and lower limits); 5. BMI between 18.0 and 28.0 kg/m2 (including upper and lower limits) and weight between 55.0 and 85.0 kg (including upper and lower limits); 6. Normal or abnormal physical examination without clinical significance; 7. The subject's routine blood tests are defined as meeting the following requirements. ? neutrophil count = 1.8 x 109/L; ? platelets = 125 x 109/L; 8. The subject's liver function indexes meet the following requirements: ? Glutathione transaminase = 1.0 x upper limit of normal (ULN); ? glutamic oxalacetic transaminase = 1.0 x upper limit of normal (ULN);
Exclusion criteria
Exclusion criteria: 1. Those who has smoked more than 5 cigarettes per day within 3 months prior to the trial; 2. Any current or past severe allergic reaction to food or medication, or allergy to tocilzumab, or severe allergy or hypersensitivity to human, humanized or murine monoclonal antibodies; 3. A history of alcohol abuse (14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 125 ml of wine) 4. Blood donation or significant blood loss (> 450 mL) in the three months prior to screening, or planning to donate blood or proposing to undergo surgery during the study; 5. Those who have taken any prescription medication, over-the-counter medication, any vitamin product or herbal remedy within 28 days prior to screening; 6. Significant changes in diet or exercise habits 2 weeks prior to screening or between screening and dosing; 7. Those who have used any biological product within 3 months prior to screening; 8. Those who have used any immunoglobulin-based biologics within 1 year prior to screening; 9. Those who have used tocilzumab or IL-6/IL-6R targeting agents; 10. Those who have any condition that increases the risk of bleeding, such as haemorrhoids with bleeding symptoms, acute gastritis or gastric and duodenal ulcers; 11. Abnormal cardiac ultrasound with clinical significance; 12. Clinically significant abnormalities in clinical laboratory tests or other clinical findings indicating clinically significant diseases of the following (including but not limited to gastrointestinal, renal, hepatic, neurological, haematological, endocrine, oncological, pulmonary, immunological, psychiatric or cardiovascular diseases); 13. Abnormal ECG with clinical significance (as judged by the investigator) or QTcF > 450ms (1 retest is allowed, if both QTcFs are > 450ms, the subject needs to be excluded); 14. Acute illness or concomitant medication from the screening period to drug administration; 15. A positive urine drug screen test or a history of substance abuse or drug use within the last five years; 16. Positive hepatitis B surface antigen on the Hepatitis B serologic test at screening; or positive hepatitis B core antibody and negative hepatitis B surface antibody; or positive hepatitis C antibody; or positive HIV antibody; or positive syphilis spirochete antibody; 17. Those who have taken any alcohol-containing product within 48 h prior to drug administration or is unable to limit alcohol consumption as required during the trial; 18. Those who have or have had malignant tumour; 19. Those who have a history of hypertension or a systolic blood pressure = 140 mmHg, or diastolic blood pressure = 90 mmHg at screening/baseline (1 retest is allowed, if the systolic blood pressure is = 140 mmHg, or diastolic blood pressure = 90 mmHg on both occasions, the subject needs to be excluded); 20. Those who have liver disease are unsuitable for enrollment in the judgement of the investigator; 21. Those who have an active infection, including acute and chronic infections as well as localised infections; 22. Active tuberculosis on chest radiograph; or a history of tuberculosis or latent tuberculosis infection or a clinical presentation suspicious of tuberculosis (including but not limited to pulmonary tuberculosis); positive gamma interferon release test for tuberculosis infection T-cell test (T-SPOT.TB); or exposure to patients with tuberculosis and/or signs and/or symptoms of suspected tuberculosis within 3 months; 23. Those who have received a live viral va
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK outcome (Plasma concentration); | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity outcome (ADA/nAb);Safety outcome (Adverse events, vital signs, physical examination, routine blood test, urinanalysis, blood biochemistry, Coagulation function, 12-lead ECG ); | — |
Countries
China
Contacts
Public ContactHu Wei
Drug Clinical Trial Research Center, The Second Affiliated Hospital of Anhui Medical University
Outcome results
None listed