Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MT-1303 in Subjects With Inflammatory Bowel Disease

An Open-Label Study to Evaluate the Safety, Tolerability, Pharmacodynamics of a Single Oral Dose of MT-1303 in Subjects With Inflammatory Bowel Disease.

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral dose of MT-1303 in subjects with inflammatory bowel disease.

This is an open-label, non-randomised, single-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of MT-1303 in subjects with inflammatory bowel disease (Crohn's Disease and Ulcerative Colitis).

Inclusion Criteria:

• A body mass index (BMI) ranging from 16 to 34 kg/m2
• Subjects who were diagnosed as Crohn's Disease or Ulcerative Colitis at least 6 months prior to Screening, clinically confirmed either by radiological, endoscopic or histological examination.
• Subjects who have had at least one flare within 18 months prior to Screening.
• Confirmed medical records of inflammatory lesions in intestinal tract

Exclusion Criteria:

• Present or past history of clinically significant gastrointestinal surgery.
• Present or past history of clinically significant stenosis, stricture or fistula in small intestine or colon.
• Known hypersensitivity to any formulation excipients.