Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Telsar Pharma Inc.
After an 11-day screening period, subjects check into a clinic, are dosed on Day 1 and stay in the clinic for 4 days to monitor pharmacokinetic and safety parameters.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subject has a previously documented diagnosis of ulcerative colitis (UC) with endoscopy and histology consistent with diagnosis
If female, the subject is at least 2 years postmenopausal or is surgically sterile per documentation provided by a third party medical professional or the subject agrees to use 2 highly effective methods of birth control during the study and is not pregnant or lactating
Subject is willing and able to comply with the study requirements
Subject has a body mass index (BMI) of \<32 kg/m2
Subject has ulcerative colitis requiring treatment with 5-aminosalicylic acid (5-ASA)
You may not be if
Subject has undergone previous resective colonic surgery
Subject has previously diagnosed Crohn's Disease based on medical history
Subject has an extension of disease limited to ulcerative proctitis
Subject has active peptic ulcer disease based on medical history
Subject is currently being treated with any prescription medication except the following: A stable dose of 5-aminosalicylic acid (5-ASA) for at least 2 weeks, oral contraceptives or hormone replacement therapy (HRT)
Subject has a history of human immunodeficiency virus (HIV)
Subject has a history of severe allergic or anaphylactic reactions
