Pharmacokinetic, Safety and Immunogenicity Study of CMAB015 and Cosentyx in Healthy Volunteers
Psoriasis
About this trial
This is an interventional treatment trial for Psoriasis
Eligibility Criteria
Inclusion Criteria: 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 <28 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. Exclusion Criteria: 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; 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; Subjects with T-SPOT test positive; 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; 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 blood-test of alcohol or not willing to ban alcohol; 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; Anti-il-17 antibody active ingredient, excipients or latex allergy; Those with anti-IL-17 antibody and anti-drug antibody positive; 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 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; Those who Can not tolerate venipunction, has a history of dizziness of needle and blood; Those who have special dietary requirements, or can not accept uniform diet; Other conditions considered inappropriate to be included in this study.
Sites / Locations
- The Second Hospital of Anhui Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Biosimilar Product
Reference Product
CMAB015 150 mg Subcutaneous injection in upper arm
Cosentyx(Secukinumab ) 150 mg Subcutaneous injection in upper arm