Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MT-1303 in Subjects With Inflammatory Bowel Disease
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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.
Condition or disease
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).
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.