Rheumatoid Arthritis
Conditions
Interventions
Abatacept Group:Single dose of abatacept
Placebo Group:Single dose of placebo
Sponsors
The First Hospital, Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: (1) Subjects are willing to participate in this study and signed informed consent; (2) Healthy subjects, as determined by no clinically significant deviation from normal in medical history, physical examination, Electrocardiograph(ECG), and clinical laboratory determinations; (3) Body weight for male must be>=50 kg, for female be>=45 kg, and all subjects must be <=100kg; (4) Body mass index (BMI) is 19-26 kg/m2 (boundary value included); (5) Men and women 18-45 years old (boundary value included); (6) Women of child bearing potential (WOCBP) must be using the adequate method of contraception to avoid pregnancy throughout the study, for 4 weeks before and for up to 10 weeks after administration of abatacept, male subjects of childbearing potential must be using an adequate method of contraception throughout the study and for up to 10 weeks after administration of investigational product in such a manner that risk of pregnancy is minimized; (7) WOCBP must have a negative serum pregnancy test within 24 hours prior to study medication administration.
Exclusion criteria
Exclusion criteria: (1) Women who are pregnant or breast-feeding; (2) History or concurrent diseases of central nervous system, cardiovascular system, renal, hepatic, digestive tract, respiratory system, metabolism and musculoskeletal system. (including but not limited to arrhythmia, bradycardia, hypotension, coronary heart disease, bronchial asthma, diabetes, hyperthyroidism, Parkinson's disease, epilepsy, shaking palsy, cancer, etc.). Or any other diseases or physiological abnormalities, which might affect study results; (3) Exposed to any investigational medication within 3 months of enrollment, or plan to receive other investigational medication during the study; (4) Prior exposure to abatacept (CTLA4-Ig), belatacept (LEA29Y) or any leukocyte depleting agent; (5) Other exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Anti-abatacept antibodies and anti-CTLA-4-T antibodies;AE; | — |
Countries
China
Contacts
Public ContactYanhua Ding
The First Hospital, Jilin University
Outcome results
None listed