Rheumatoid arthritis
Conditions
Interventions
Case series:Comparing Topiramab (IA001 injection) produced by two companies
Sponsors
Hospital affiliated to Changchun University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. The subjects fully understand the content, nature, method and possible adverse reactions of the test, voluntarily act as the subjects, sign the informed consent before the test, and can complete the test according to the requirements of the scheme; 2. Willing and able to follow the visit and treatment specified in this study; 3. The subjects (including partners) are willing to take effective contraceptive measures without family planning in the next 6 months; 4. Healthy male subjects aged from 18 to 55 years (including the boundary value); 5. The body weight of male subjects >=50kg and <=80kg; body mass index (BMI = weight / height square (kg / m2) in the range of 18-26kg / m2 (including the critical value); 6. After comprehensive examination, including vital signs, physical examination, laboratory examination and ECG examination, chest X-ray (positive position), abdominal color ultrasound (liver, gall bladder, spleen and pancreas), it is normal or abnormal without clinical significance.
Exclusion criteria
Exclusion criteria: 1. It is known that it is allergic to toluzumab injection or its auxiliary materials; it has a history of allergic diseases or allergic constitution; 2. There is an unhealed wound ulcer or fracture, or major surgery is performed within 3 months before the infusion of the study drug, or major surgery is expected within the study period or 2 months after the end of the study; 3. Drug screening positive or drug abuse history in the past 5 years or drug use within 3 months before the test; 4. Blood donation or massive blood loss (> 450ml) within 3 months before the use of the study drug; 5. Those who received blood transfusion within 8 weeks; 6. Those who drink more than 14 units of alcohol per week (1 unit of alcohol = 285ml of beer or 25ml of spirits or 100ml of wine with 40% alcohol content) or have taken products containing alcohol two days before administration within 6 months before screening; 7. Patients with previous diseases of immune system, neuropsychiatric system, respiratory system, cardiovascular system, digestive system, haemolymph system, liver and kidney dysfunction, endocrine and metabolic system, skeletal and muscular system or other diseases, and the researchers judged that the previous medical history may have an impact on drug metabolism or safety; 8. Those with abnormal examination and clinical significance in screening period; 9. Taking any prescription, over-the-counter, vitamin product or herbal medicine within 14 days prior to the use of the study drug; 10. Difficulty in venous blood collection or inability or unwillingness to undergo repeated venipuncture (for example, due to poor tolerance or lack of venous access); 11. Those who have participated in clinical trials of any drug or medical device within 3 months before the application of the drug; 12. Those who have received any live (attenuated) vaccine within 2 months before the infusion of the study drug or who plan to receive live (attenuated) vaccine during the screening and study visit; 13. Used within 12 months before the administration of the study drug or planned to receive any monoclonal antibody or biological drug within 12 months after the administration of the study drug; 14. Hepatitis (including hepatitis B and C), AIDS and syphilis screening positive; 15. Those who smoked more than 5 cigarettes per day 3 months before the test; 16. Unable or unable to comply with the ward management regulations, poor compliance during the study period, or unable to complete the study in accordance with the program requirements; 17. The subject is unable to complete the test due to personal reasons; 18. The researcher thinks it is not suitable to be included in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cmax;AUC0-t; | — |
Secondary
| Measure | Time frame |
|---|---|
| AUC0-8;t1/2;Tmax;CLz;?z;Vz;MRT; | — |
Countries
China
Contacts
Public ContactSun Changcheng
Liaoning Grand Nuokang Biopharmaceutical Co., Ltd
Outcome results
None listed