A Phase 1 Single Dose Study to Assess the Pharmacokinetics and Safety of the Biosimilar Ustekinumab Healthy Volunteers

Exclusion Criteria39

• Any clinically significant abnormality at physical examination or clinically significant
• abnormal laboratory test results at screening or Day -1.
• Positive test for HIV, hepatitis B, or hepatitis C found during medical screening.
• Positive pregnancy test at screening or Day -1.
• History of allergic reactions to ustekinumab or other related drugs, or to any excipient in the
• formulation.
• History of previous exposure to ustekinumab or other anti-IL12/23 molecules for a medical
• condition or in the context of another clinical research study.
• Clinically significant 12-lead ECG abnormalities or vital sign abnormalities at screening.
• History of significant drug abuse within 1 year prior to screening or positive urine drug
• screen
• History of significant alcohol abuse within 1 year prior to screening or regular use of alcohol
• within 6 months prior to the screening visit
• Participation in a clinical research study involving the administration of an investigational or
• marketed drug or device within 30 days or 5 half-lives of the previous drug
• Use of medications for the timeframes specified below, with the exception of medications
• exempted by the Investigator on a case-by-case basis because they are judged unlikely to
• affect the PK profile of the study drug or subject safety (e.g., topical drug products without
• significant systemic absorption) and hormonal contraceptives
• Have received a live attenuated vaccine within 1 month prior to screening or plan to receive
• such vaccination during the study.
• Donation of plasma within 7 days prior to dosing. Donation or loss of blood of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to drug administration.
• Breast-feeding subject.
• History of cancer, including any form of skin cancer, or strong family history of cancer
• History of relevant anaphylactic reactions, drug, or food allergies.
• Self or any first degree relative history with known disturbance of coagulation or blood disorder which would be cause for anemia or excess bleeding Inclusion of subjects with first degree relative history of thalassemia will be at the discretion of the
• Investigator.
• Any confirmed or suspected immunosuppressive or immunodeficient condition based on
• medical history, family history, and physical examination.
• History of clinically significant opportunistic infection
• History of serious local infection or systemic infection within 3 months prior to screening.
• History of recurrent infections, including recurring sinus and respiratory infections.
• Presence of fever within 2 weeks prior to drug administration.
• History of active tuberculosis or presence of active or latent tuberculosis, or positive
• QuantiFERON®-TB test indicating possible tuberculosis infection.
• Have resided or travelled in regions where tuberculosis or mycosis is endemic within
• month prior to screening, or plan to visit such a region during the study.
• Any reason which, in the opinion of the Investigator, would prevent the subject from
• participating in the study.