Porównanie farmakokinetyki, bezpieczeństwa stosowania, tolerancji i immunogenności preparatu CKD-704 (leku biopodobnego do risankizumabu), leku Skyrizi® dopuszczonego do obrotu w UE oraz leku Skyrizi® posiadającego licencję w USA u zdrowych, dorosłych uczestników

Kryteria wyłączenia kto nie może wziąć udziału (24)

1. History of previous exposure to any anti-IL-12/23 or anti-IL-23 treatment
2. History of relevant drug and/or food allergies
3. History of hypersensitivity to Skyrizi or their constituents
4. Presence of psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary procedures
5. Medical history, findings of physical examination/laboratory tests indicate a clinically significant disorder, condition, or disease that, in the opinion of the Investigator would pose a risk to participant safety
6. Major surgery within 12 weeks prior to the randomization into the study
7. Documented active or suspected malignancy or history of malignancy within 5 years prior to screening
8. Positive tests for hepatitis B surface antigen, Hepatitis B core antibody, hepatitis C virus antibody, or human immunodeficiency virus (HIV)-1 and HIV-2 antibody at screening
9. Positive test for severe acute respiratory syndrome coronavirus 2 on admission (optional)
10. Any current active infections or any recent history (within 1 week prior to study intervention administration) of active infections
11. Participant has a history of tuberculosis (TB) diagnosis or evidence of active or latent infection with Mycobacterium tuberculosis
12. Abnormal hepatic, renal, or hematological laboratory tests. In such cases, the assessment may be repeated once at screening and admission. The Investigator will check reassessment results to decide if the value is clinically significant and if participant is eligible to receive the treatment
13. Any other laboratory value outside the reference range that the Investigator considers to be of clinical significance
14. Abnormal vital signs(Systolic blood pressure < 90 mmHg or > 140 mmHg, Diastolic blood pressure < 50 mmHg or > 90 mmHg, Heart rate < 45 or > 100 beats per minute)
15. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG and any clinically important abnormalities in the 12-lead ECG
16. Any past or concurrent medical conditions, or clinically important active infection that could potentially increase the participant's risks or that would interfere with the study evaluation, procedures, or study completion
17. Have used any prescription or non-prescription medicines or vitamins within 7 days or 5 half-lives (whichever is longer) of admission, unless in the Investigator's opinion will not affect determination of safety or other study assessments
18. Male or females participating in any other clinical trial at the time of consenting
19. Have received any investigational drug within 30 days prior to screening, with minimal washout of at least 5-half-lives of any previous investigational drug, whichever is longer
20. Have received live vaccines during the past 4 weeks before screening or have the intention to receive vaccination during the 21-week treatment and assessment period
21. Participant has donated blood (> 500 mL) or blood products within 2 months (56 days) prior to screening
22. History of drug abuse or alcohol abuse as judged by the Investigator or designee
23. Participant is affiliated with the site or Sponsor and/or may be considered to be consenting under duress
24. Participant is unlikely to co-operate with the requirements of the study