Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis

Inclusion Criteria: Healthy Volunteers

- 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

- Additional inclusion criteria apply

Inclusion Criteria: Subjects with Mild to Moderate Ulcerative Colitis

- 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

- Additional inclusion criteria apply

Exclusion criteria: Healthy Volunteers

- 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

- Additional exclusion criteria apply

Exclusion criteria: Subjects with Mild to Moderate Ulcerative Colitis

- 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

- Additional exclusion criteria apply