Bioequivalence Phase I Study of BFI-751 Compared With EU and US-STELARA® in Healthy Adults

Exclusion Criteria

• •Healthy volunteers will be excluded from the study if there is evidence of any of the following at screening or after check-in on Day -1, prior to dose administration:
• •1. 1\. Prior exposure to STELARA® (Ustekinumab).
• •2. Have a history of hypersensitivity or allergic reactions (either spontaneous or following drug administration) to any of the active or formulation ingredients of the study treatments components.
• •3. Have a history of or presence of disease determined by the PI to be clinically significant including:
• •1. gastrointestinal (including diverticulitis, stomach ulcers, inflammatory intestinal disease, gastrointestinal perforations/fistulae/intra-abdominal abscess).
• •2. any other internal, non-gastrointestinal fistulae that is at an increased risk of bleeding.
• •3. haematological (including pancytopenia, aplastic anaemia or blood dyscrasia).
• •4. renal, hepatic, pulmonary, neurologic, psychiatric, metabolic (including known diabetes mellitus), or
• •5. allergic disease excluding mild asymptomatic seasonal allergies.
• •4. Have a history of prolonged immunosuppressant therapy, or photochemotherapy treatment.
• •5. Presence or evidence of recent sunburn, scar tissue, tattoo (more than 25% of body area), open sore or branding that, in the opinion of the Investigator, would interfere with interpretation of skin adverse reactions.
• •6. Have a history of and/or current cardiac disease defined as one of the following:
• •1. History of congestive heart failure; angina pectoris requiring anti-anginal medication.
• •2. Evidence of transmural infarction on ECG.
• •3. History of sustained hypertension (systolic \> 180 mmHg and/or diastolic \> 100 mmHg) or hypertensive crisis or hypertension encephalopathy.
• •4. Clinically significant valvular heart disease, or severe arterial thromboembolic events.
• •7. Have a positive test result for hepatitis B surface antigen (HBsAg), hepatitis C virus, human immunodeficiency virus (HIV) or history of active, latent or inadequately treated tuberculosis (TB) infection.
• •8. Positive serum pregnancy test for women of childbearing potential at the Screening visit or positive urine pregnancy test with confirmatory serum pregnancy test prior to dosing on Day 1.
• •9. Females who are breastfeeding.
• •10. Have a history of cancer including lymphoma, leukaemia and skin cancer (volunteers with a maximum of 1 surgically resected basal cell carcinoma or squamous cell carcinoma are permitted).
• •11. Have an illness within 30 days prior to screening, or prior to dosing, that is classed as clinically significant by the Investigator.
• •12. Prior exposure to any investigational monoclonal antibody within 12 months or 5 half-lives of the previous drug (if known), whichever is longer, prior to study drug administration.
• •13. Have participated in another clinical study of an investigational drug (excluding monoclonal antibody) within 30 days or 5 half-lives of the investigational drug (whichever is longer) prior to the administration of the study drug, or are currently participating in another clinical study of an investigational drug, or intending to participate in another clinical study of an investigational drug before completion of all scheduled evaluations in this clinical study.
• •14. Any clinically significant infection, in the opinion of the Investigator, ongoing at screening or admission to the clinical unit.
• •15. Have had major surgery within 30 days prior to screening or will have an operation between screening and the end of study visit, or have any unhealed wound, including wound dehiscence and wound healing complications requiring medical intervention.
• •16. Have received any vaccine(s) within 14 days prior to check in on Day -1, or is planning to receive any vaccine with 14 days following dose administration on Day 1.
• •17. Have received a Bacillus Calmette-Guerin (BCG) vaccination within 1 year prior to dose administration, or is planning to receive a BCG vaccination within 1 year following dose administration.
• •18. History of alcohol abuse (defined as more than 12 standard drinks per week or more than 4 standard drinks on \> 3 days per week; where 1 standard drink is 10 g of pure alcohol and is equivalent to 285 mL beer \[4.9% Alc./Vol\], 100 mL wine \[12% Alc./Vol\], 30 mL spirit \[40% Alc./Vol\]) within 12 weeks prior to the screening visit.
• •19. Positive drug or alcohol test results. In the event the urinary drug test is positive, the test may be repeated once (at the discretion of the PI) to confirm eligibility.
• •20. Have donated \> 100 mL blood within 4 weeks prior to the administration of the study drug.
• •21. Abnormal or irregular bowel movements, in the opinion of the Investigator.
• •22. Any history of non-traumatic haemorrhage (i.e. any haemorrhage requiring medical intervention) or any condition which may increase bleeding risk including clotting disorders, thrombocytopenia (platelet count \< 150, 000 per μL) or an international normalised ratio higher than 1.5.
• •23. Impaired liver function as determined by a serum alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)\> 1.5 x upper limit of normal (ULN) at screening or admission. Subjects with values between ULN and 1.5 x ULN may be included in the study if considered not clinically significant by the Investigator.
• •24. Use of any prescription or over-the-counter medication (including herbal products, diet aids, and hormone supplements) within 10 days or 5 half-lives of the medication (whichever is longer) prior to the first study drug administration, which, in the opinion of the Investigator, could affect the outcome of the study. The following exceptions apply:
• •1. Contraceptives for WOCBP are permitted.
• •2. Paracetamol (up to a maximum of 4 doses of 500 mg per day, and no more than 3g per week) is permitted.
• •3. Ibuprofen (up to a maximum of 4 doses of 200 mg per day) is permitted.
• •25. Consumption of any foods containing poppy seeds within 48 hours prior to screening and admission to the clinical centre.
• •26. Presence of proteinuria (other than trace amounts i.e., +, ++/+++).
• •27. Personal history of venous thromboembolic events or idiopathic venous thromboembolic events in a first degree relative.
• •28. Any person who is an employee of an Investigator or Sponsor, or an immediate relative of an Investigator.
• •29. Any other condition or prior therapy that in the opinion of the Investigator would make the volunteer unsuitable for this study, including inability to cooperate fully with the requirements of the study protocol or likelihood of noncompliance with any study requirements.