Pharmacokinetic, Safety and Immunogenicity Study of New Process CMAB015 and Cosentyx in Healthy Volunteers

Korábbi kezelés

• Those who smoked more than 5 cigarettes per day in the 6 months before screening and did not cooperate with smoking bans during the study period；
• Drug abusers, or drug users in the 3 months prior to screening, or excessive daily consumption of tea, coffee and/or caffeinated beverages (more than 8 cups, 1 cup =250mL) in the 3 months prior to screening, or positive urine drug screening；
• Surgery within 4 weeks prior to screening; Or plan to have surgery during the study period；
• Use of any prescription drug, over-the-counter drug or health product within 4 weeks prior to screening, or prior use of such drug or health product within 5 half-lives, whichever is longer；
• Those who have used any biological agent, including live vaccine, in the 3 months prior to screening, or who plan to receive live vaccine during the study period；
• Those with anti-IL-17 antibody and anti-drug antibody positive；
• Those who had lost blood or donated at least 400 mL in the 3 months prior to the trial, or had lost blood or donated at least 200 mL in the 1 month prior to screening, or planned to donate blood during the trial；

Más betegség

• Patients with serious diseases such as cardiovascular system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematopoietic system, immune system, or any of the above diseases；
• Patients with currently active infected diseases；
• Subjects with past or current inflammatory bowel disease;
• History of malignant neoplasms within the last 5 years (other than completely resected basal cell or squamous cell carcinoma of the skin in situ)；
• Any one of HBV surface antigen, HCV antibody, HIV antibody, treponema pallidum antibody positive；
• Anti-il-17 antibody active ingredient, excipients or latex allergy；
• Those who Can not tolerate venipunction, has a history of dizziness of needle and blood；
• Other conditions considered inappropriate to be included in this study.

Egyéb

• After comprehensive examination (vital signs, physical examination, electrocardiogram, chest radiography, abdominal B-ultrasound, blood routine, urine routine, blood biochemistry, etc.), any examination item was judged abnormal by the investigator and had clinical significance;
• Subjects with T-SPOT test positive. If the initial T-SPOT test result is inconclusive, a repeat test may be performed. If the result remains inconclusive or positive, the individual should be excluded；
• Alcoholics，or participants who consumed more than 14 units of alcohol per week (1 unit = 17.7mL ethanol, i.e., 1 unit = 357mL 5% beer or 43mL 40% liquor or 147mL 12% wine) during the preceding 3 months were screened，or who have positive result in breath-test of alcohol or not willing to ban alcohol；
• Those who have been enrolled in other clinical studies or less than 3 months since the end of the most recent clinical study；
• Those who have special dietary requirements, or can not accept uniform diet；

• Healthy male volunteers, age ranged 18 to 45 years (both inclusive)；
• Subjects with body weight of ≥50 kg and ≤ 75 kg and BMI ≥18 and <26 kg/m2 ;
• Subjects and their partners were willing to use medically approved contraceptive methods within 6 months of study administration, partners did not plan to become pregnant, subjects did not plan to donate sperm；
• The subjects have the ability to understand the full characteristics and objectives of the study, including the possible risks and side effects of the study; Moreover, the subjects can communicate well with researchers and complete the research according to the regulations；
• Subjects voluntarily sign ICF prior to the study.