Rheumatoid arthritis, Psoriasis, Ankylosing Spondylitis
Conditions
Interventions
experimental group:TNF-a 40mg
control group:humira 40mg
Sponsors
Phase I Clinical Laboratory of Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1) Healthy male adult subjects, fully aware of the test content, nature, method and possible adverse reactions, volunteered as subjects, and signed informed consent before the trial, and were able to complete the experiment according to the requirements of the protocol; 2) Willing and able to follow the visit and treatment stipulated in this study; 3) 18 years old <= age <= 55 years old (including boundary value); 4) Body mass index (BMI): 19.0-28.0 kg / m2 (including boundary value); 5) Subjects (including partners) were willing to have no family planning within 6 months after administration of the study drug and voluntarily took effective contraceptive measures.
Exclusion criteria
Exclusion criteria: 1) According to the researcher's judgment, patients with abnormal ECG (with clinical significance) or abnormal vital signs (systolic blood pressure = 140mmHg; diastolic blood pressure = 90mmHg); 2) Patients with immune system, neuropsychiatric system, respiratory system, cardiovascular system, digestive tract system, haemolymph system, liver and kidney insufficiency, endocrine and metabolic system, musculoskeletal system disease or other diseases in the past, and the researcher judged that the previous medical history may have an impact on drug metabolism or safety; 3) They are known to be allergic to adalimumab injection or its excipients, and have a history of allergic diseases or allergic constitution; 4) Patients with history of tuberculosis or latent tuberculosis infection or suspected tuberculosis patients with clinical manifestations (including but not limited to pulmonary tuberculosis), or chest X-ray shows active pulmonary tuberculosis; 5) Those who have used any monoclonal antibody or biological drugs (including vaccines and other biological products) within 12 months before the administration of the study drug or plan to receive any monoclonal antibody or biological drugs within 12 months after the administration of the study drug; 6) Patients with unhealed wound ulcer or fracture, or major surgery within 3 months before infusion of study drug or expected to undergo major surgery during the study period or within 2 months after the end of the study; 7) Participated in clinical trials of any other drugs or medical devices within 3 months before enrollment, or planned to participate in clinical trials of other drugs or medical devices during the research process; 8) Taking any prescription drug, over-the-counter drug, any vitamin product or herbal medicine within 14 days prior to the use of the study drug; 9) Blood donation or massive blood loss (> 450ml) within 3 months before using the study drug; 10) Those who have received blood transfusion within 8 weeks; 11) In the screening period, all the examinations were abnormal and had clinical significance; 12) Unable or unable to comply with ward management regulations, poor compliance during the study period, or unable to complete the study according to the program requirements; 13) The subjects were unable to complete the experiment due to personal reasons; 14) The researchers think it is not suitable to be included in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t;Adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-8;T1/2;Tmax;Vd; | — |
Countries
China
Contacts
Public ContactYang Haimiao
Affiliated Hospital of Changchun University of Traditional Chinese Medicine
Outcome results
None listed