A First Time in Human Study in Healthy Volunteers and Patients

Inclusion criteria

• Parts 1 and 2

• Adult male subjects aged 18 to 45 years inclusive.
• Body mass index (BMI) between 18.0 and 32.0 kg/m2 inclusive.
• Body weight between 50.0 and 100.0 kg inclusive.
• Subjects who are healthy as determined by pre study medical history, physical examination and 12-lead ECG, and clinical laboratory tests
• Part 3

• Adult male or female subjects aged 18 to 65 years.
• Ileostomy for a minimum of 18 months for a non malignant disease indication.
• A BMI between 18.0 and 32.0 kg/m2 inclusive.
• Body weight between 50.0 and 100.0 kg inclusive.
• Subjects who are healthy as determined by pre study medical history, physical examination and 12-lead ECG, and clinical laboratory tests
• Part 4

• Adult male or female subjects aged 18 to 65 years.
• A confirmed diagnosis of Crohn's disease for a minimum of 6 months.
• A BMI between 15.0 and 32.0 kg/m2 inclusive.
• Subjects who have no other significant co-morbidity (other than those associated with Crohn's disease).
• Subjects whose medical history, physical examination, clinical laboratory test results and 12-lead ECG have no clinically relevant abnormalities (other than those associated with Crohn's disease).

Exclusion criteria

• Parts 1 and 2

• 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.
• A history of severe allergies, non-allergic drug reactions, or multiple drug allergies.
• A known hypersensitivity to TNF inhibitors or any of the inactive ingredients of the study treatment.
• A history of significant gastrointestinal (GI) disease, including GI motility disorders, GI malignancy or of polyposis coli.
• Previous surgery to the GI tract with the exception of appendectomy.
• A history of malignancy.
• Any other condition which in the investigator's opinion will interfere with the trial or interpretation of the results.
• Part 3

• A history of Crohn's disease.
• 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.
• A history of severe allergies, non-allergic drug reactions, or multiple drug allergies.
• A known hypersensitivity or contraindication to TNF inhibitors or any of the inactive ingredients of the study treatment.
• A known history of heart disease.
• Any clinical evidence of active inflammatory bowel disease.
• Any other condition which in the investigator's opinion will interfere with the trial or interpretation of the results.
• Part 4

• 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.
• Having ever received anti-TNF-α therapy or other biologics.
• Required an increase in dose of either steroids or immunosuppressant therapy within the past 6 weeks.