Psoriasis
Conditions
Interventions
BAT2206 vs Stelara (EU-licensed) vs Stelara (US-licensed):BAT2206 injection, 45mg
Stelara (EU-licensed)
45mg
Stelara (US-licensed), 45mg
Sponsors
The First Hospital of Jinlin University
Eligibility
Sex/Gender
Male
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Chinese male healthy subjects aged from 18 to 55 years (including the boundary value); 2. BMI between 18-28kg/m2 (including boundary value) and body weight between 55-85kg; 3. Normal physical examination results or abnormal with no clinical significance according to the doctor's judgment; 4. The subject (including partner) has no pregnancy plan or sperm donation plan during the whole trial period and within 6 months after the completion of the study, and voluntarily adopts effective contraceptive measures; 5. Sign the informed consent before joining the study, and fully understand the content, process and possible risks; 6. Willing and able to comply with the visits and treatments of the trial protocol.
Exclusion criteria
Exclusion criteria: 1. Clinical laboratory examination results are abnormal and with clinical significance, or other clinical findings indicate diseases with clinical significance within one year prior to screening; 2. ECG is abnormal and has clinical significance (judged by the investigator); 3. With active infection within two months before screening, including acute and chronic infection and local infection; 4. Hepatitis B and/or Hepatitis C; or HIV antigen/antibody positive; or Treponema pallidum antibody positive; 5. Having taken any prescription drug, over-the-counter drug, any vitamin product or herbal medicine within 28 days before screening (or within 5 half lives of the above drugs, whichever is longer); 6. Having participated in drug clinical trials within 3 months before the study administration, or planning to participate in other drug clinical trials during the study period; 7. Acute disease occurred or with concomitant medication from the screening to use of the study drug; major injury or surgery or fracture occurred within 4 weeks before enrollment, or surgery was planned during the study; 8. Having used ustekinumab, TNF or IL targeting agents, or having used any biological products or monoclonal antibodies within 3 months before screening; 9. Any immunoglobulin biologicals were used one year prior to screening; 10. Having received within 12 weeks prior to initiating treatment or planning to receive live virus or live vaccines during the study; 11. Suspected or confirmed as allergic constitution (allergic to variaty of drugs or food), or allergic to ustekinumab, or severe allergic or allergic reaction to monoclonal antibody; 12. Blood donation or massive blood loss (> 450 ml) within 3 months before using the study drug, or planning to donate blood during the study, or having received blood transfusion within 8 weeks before screening; 13. Employees or relatives of all investigators, clinical centers, clinical research organizations or sponsors cannot be included in the group; 14. Subjects considered unsuitable by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PK; | — |
Countries
China
Contacts
Public ContactYanhua Ding
the First Hospital of Jinlin University
Outcome results
None listed