Status:
TERMINATED
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181 in Healthy Subjects and Subjects With Mild to Moderate Ulcerative Colitis
Lead Sponsor:
Amgen
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
To assess the safety and tolerability of single subcutaneous (SC) and intravenous (IV) doses of AMG 181 in healthy subjects and of a single SC dose in subjects with mild to moderate ulcerative colitis...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT01164904
Start Date
July 1 2010
End Date
March 1 2013
Last Update
July 25 2013
Active Locations (10)
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1
Research Site
Glendale, California, United States, 91206
2
Research Site
Danbury, Connecticut, United States, 06810
3
Research Site
Plymouth, Minnesota, United States, 55446
4
Research Site
Duncansville, Pennsylvania, United States, 16635