Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
18–55
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Healthy male or female subjects of non-reproductive potential between 18 to 45 year-of -age
Body Mass Index (BMI) between 18 and 34 kg/m2
Normal physical and neurological examination, clinical laboratory values and ECG
Male or female subjects between 18 to 55 year-of -age
Body Mass Index (BMI) between 18 and 34 kg/m2
Diagnosis of Ulcerative Colitis for at least 2 months
Active, mild to moderate disease as defined by an Ulcerative Colitis Disease Activity Index (UCDAI, aka Mayo score) score of 4 to 9 (inclusive), with a minimum sigmoidoscopy score of 1
You may not be if
History or evidence of a clinically significant disorder (including psychiatric), condition or disease that would pose a risk to subject safety or interfere with the study evaluations, procedures or completion
History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers within the past 5 years
Recent or on-going infection(s)
Underlying condition(s) that predisposes the subject to infections
Disease limited to the rectum, i.e. within 20 cm of the anal verge
Any prior gastrointestinal surgery
Evidence of severe disease (as evidenced by an Hb concentration \<11g/dL; toxic megacolon, or an UCDAI score≥10)
Immunosuppressive therapy with either azathioprine, methotrexate, or mercaptopurine, within the past 3 months
Prior exposure to a biologic agent or cyclosporine A
Use of antibiotics within the past 2 weeks of screening and during screening period
Use of topical (e.g. suppository or enema) mesalamine or steroids within two weeks prior to day 1
Clareo Health | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis
