Psoriasis
Conditions
Interventions
Group A:CMAB015 injection (dosage 1)
Group B:Cosentyx (dosage 2)
Sponsors
The Second Hospital of Anhui Medical University
Eligibility
Sex/Gender
Male
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-45 years, healthy males; 2. 50-75 kg and body mass index(BMI) 18-28 kg/m2; 3. Volunteers and/or their partners are willing to use medically approved contraception within 6 months after the end of the trail, their partners have no plans to become pregnant, and the volunteers have no plans to donate sperm; 4. Volunteers have the ability to understand the full characteristics and purpose of the study, including the possible risks and side effects of the study; and is able to communicate well with the investigator and to complete the study in accordance with the study protocol; 5. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Any examination item judged by the investigator to be abnormal and clinically significant after a comprehensive examination (vital signs, physical examination, electrocardiogram, chest X-ray, abdominal ultrasound, blood routine, urine routine, blood biochemistry, etc.); 2. Previous major diseases of the cardiovascular system, endocrine system, nervous system, digestive system, respiratory system, genitourinary system, hematopoietic system, immune system, or current disease of any of these systems; 3. Those with current active infections; 4. Those with previous or current inflammatory bowel disease; 5. Those with a history of malignancy within the last 5 years (except for completely excised in situ basal or squamous cell carcinoma of the skin); 6. Those who are positive for any one of HBV surface antigen, HCV antibody, HIV antibody, or syphilis spirochete antibody; 7. Those with positive T-SPOT test; 8. Those who smoked more than 5 cigarettes per day on average in the 6 months prior to screening, and those who cannot cooperate with abstinence from smoking during the trial; 9. Alcohol abusers or those who have consumed more than 14 units of alcohol per week (1 unit = 17.7 mL of ethanol, i.e., 1 unit = 357 mL of beer at 5% alcohol or 43 mL of white wine at 40% alcohol or 147 mL of wine at 12% alcohol) within 3 months prior to screening, or those who have a positive blood test for alcohol, and those who are unable to cooperate with abstinence from alcohol during the trial; 10. Substance abusers, or those who have used drugs within 3 months prior to screening, or those who have consumed excessive amounts of tea, coffee, and/or caffeinated beverages (more than 8 cups, 1 cup = 250mL) on average per day within 3 months prior to screening, or those who have had a positive urine drug screen; 11. Those who have received surgical procedures within 4 weeks prior to screening; or who have plans to have surgery during the trial; 12. Those who have used any prescription drugs, over-the-counter drugs, or supplements within 4 weeks prior to screening, or who have previous use of the above drugs or supplements not exceeding 5 half-lives (whichever is longer); 13. Those who have used any biological agent, including live virus vaccines, within 3 months prior to screening, or who plan to receive live virus vaccines during the trial; 14. Those who are allergic to the active ingredient, excipients or latex of anti-IL-17 antibodies; 15. Those who are positive for anti-drug antibodies of anti-IL-17 antibody; 16. Those who are currently enrolled in another clinical trial or less than 3 months from the end of the most recent enrolled clinical trial; 17. Those who have lost or donated >= 400 mL of blood within 3 months prior to the trial, or have lost or donated >= 200 mL of blood within 1 month prior to screening, or plan to donate blood during the trial. 18. Those who cannot tolerate venipuncture and have a history of needle sickness and blood sickness; 19. Those who have special dietary requirements and cannot accept a uniform diet; 20. Other conditions that the investigator considers inappropriate for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum drug concentration; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital sign;Physical examination;Blood routine examination;Blood biochemistry;Urine routine examination;Antinuclear antibody, ANA;12 lead electrocardiograph (ECG);Anti-drug antibody, ADA;Neutralizing Antibody, NAb;Adverse effect;Pharmacokinetic parameters; | — |
Countries
China
Contacts
Public ContactWei hu
The Second Hospital of Anhui Medical University
Outcome results
None listed