Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Amgen
Age
18–65
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
Body Mass Index (BMI) between 18 and 34 kg/m2
Normal physical and neurological examination, clinical laboratory values and ECG
Ulcerative Colitis Disease Activity Index (UCDAI, aka Mayo score) score of 4 to 10 (inclusive), with a minimum sigmoidoscopy score of 1; (for subjects with ulcerative colitis)
Crohn's Disease Activity Index (CDAI) score of \>150 and \< 450 at screening (for subjects with Crohn's disease)
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
Underlying condition(s) that predisposes the subject to infections
Disease limited to the rectum, i.e. within 10 cm of the anal verge (for subjects with ulcerative colitis)
Evidence of severe disease (as evidenced by an Hb concentration less or equal to 10g/dL; toxic megacolon, or an UCDAI score greater than 10) (for subjects with ulcerative colitis)
Subject has short bowel syndrome (for subjects with Crohn's disease)
Presence of an ostomy (for subjects with Crohn's disease)
Presence of a fistula (for subjects with Crohn's disease)
Clareo Health | Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.
