A First Time in Human Study in Healthy Volunteers and Patients

Exclusion Criteria

• •Parts 1 and 2
• •1. A clinically significant abnormal medical history or clinically significant abnormal physical examination, including history of febrile illness within 1 week prior to the first dose.
• •2. A history of severe allergies, non-allergic drug reactions, or multiple drug allergies.
• •3. A known hypersensitivity to TNF inhibitors or any of the inactive ingredients of the study treatment.
• •4. A history of significant gastrointestinal (GI) disease, including GI motility disorders, GI malignancy or of polyposis coli.
• •5. Previous surgery to the GI tract with the exception of appendectomy.
• •6. A history of malignancy.
• •7. Any other condition which in the investigator's opinion will interfere with the trial or interpretation of the results.
• •Part 3
• •1. A history of Crohn's disease.
• •2. A clinically significant abnormal medical history (other than the condition leading to ileostomy) or clinically significant abnormal physical examination, including history of febrile illness within 1 week prior to the first dose.
• •3. A history of severe allergies, non-allergic drug reactions, or multiple drug allergies.
• •4. A known hypersensitivity or contraindication to TNF inhibitors or any of the inactive ingredients of the study treatment.
• •5. A known history of heart disease.
• •6. Any clinical evidence of active inflammatory bowel disease.
• •7. Any other condition which in the investigator's opinion will interfere with the trial or interpretation of the results.
• •Part 4
• •1. Subjects with severe Crohn's disease such as: those requiring surgery; those with a current abscess; those with a non inflammatory stricture; those with a history of obstruction.
• •2. Having ever received anti-TNF-α therapy or other biologics.
• •3. Required an increase in dose of either steroids or immunosuppressant therapy within the past 6 weeks.