Rheumatoid arthritis
Conditions
Interventions
HS628 group versus Actemra group:A single drug delivery
Sponsors
Shanghai Xuhui District Central Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must be able to comprehend and willing to sign the Informed Consent Form (ICF); 2. Those who can comply with the requirements of this experiment, can carry out various examinations according to the plan and can report subjective symptoms; 3. Aged 18 to 40 years old (subject to the date of signing the informed consent), healthy male; The body mass index (BMI) is between 19 and 26 kg/m2 (including 19 kg/m2 and 26 kg/m2), and the body weight is between 50 and 80 kg (including 50 and 80 kg).
Exclusion criteria
Exclusion criteria: 1. Participated in other clinical trials within 3 months before signing the informed consent form; 2. Blood donation (including component blood) or blood loss of more than 400 mL within 3 months before signing the informed consent, or blood transfusion; Blood donation (including component blood) or blood loss of more than 200 mL within 1 month before signing the informed consent; 3. Those who have serious bleeding factors that affect venous blood collection or are unable/unwilling to receive intravenous puncture; 4. Single or test for bead with allergy to any ingredient in the drug, or has a history of drug or food allergies, or do you have any special dietary requirements, or specific history of allergy, asthma, rubella, eczema, dermatitis), or for related equipment used by experiment (such as syringe needle or intravenous drip needles, or intravenous drip hose) allergies; 5. Subjects with a clear history of neurological or psychiatric disorders (including epilepsy or dementia), immunodeficiency or immunosuppressive disease, malignancy, or heart failure, or those who had major surgery within 6 months prior to signing the informed consent form; 6. Currently suffering from central nervous system, cardiovascular system, kidney, liver, digestive system, respiratory system, metabolic system, mental disease or other significant diseases, or other diseases that can affect drug absorption and metabolism; 7. Previous or latent infection with mycobacterium tuberculosis (gamma-interferon release test (t-spot) positive); 8. Have any invasive infection within 4 weeks before signing the informed consent form; 9. Those who received BCG vaccine within 12 months before signing the informed consent, or had received any live vaccine within 6 months before signing the informed consent; 10. Subjects have previously received anti-il-6 medication or othermonoclonal antibody therapy, or have used or are currently using any biological agent within 6 months prior to signing the informed consent form; 11. Those who have received any drug therapy (including prescription drugs, non-prescription drugs, biological products, proprietary Chinese medicines, vitamins, dietary supplements, etc.) and health care products within 4 weeks before signing the informed consent, or those who have not passed 5 half-life of previous therapeutic drugs before the use of experimental drugs, whichever is the older; 12. Those who have received warfarin, cyclosporine, theophylline or statins within 3 months prior to signing the informed consent, or who may receive the above drugs during the expected trial period; 13. Those who plan to perform surgery (including cosmetic surgery, dental surgery and oral surgery) during the trial period or those who plan to participate in vigorous exercise (including contact exercise or bump exercise) during the trial period; 14. Heavy drinkers or frequent drinkers within 3 months prior to the signing of the informed consent, i.e., those who drank more than 14 units of alcohol (14 bottles of 360 mL beer or 630 mL spirits with a 40% alcohol content or 2100 mL wine) per week, or who were positive on the alcohol blowing test; 15. Have used soft drugs (such as marijuana) or hard drugs (such as cocaine and benzodiazepine) within 3 months before signing the informed consent;(morphine, THC, methamphetamine, dimethylene dioxyamphetamine, ketamine and cocaine); 16. Smoking more than 5 cigarettes per day in the 6 months before signing the informed c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK; | — |
Countries
China
Contacts
Public ContactChen Yu
ShangHai XuHui District Central Hospital
Outcome results
None listed