Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.
NCT ID: NCT01290042
Last Updated: 2015-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
43 participants
INTERVENTIONAL
2011-02-28
2014-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
QUADRUPLE
Study Groups
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Placebo arm
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
Placebo for AMG 181
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
Active arm
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
AMG 181
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
Interventions
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AMG 181
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
Placebo for AMG 181
Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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)
18 Years
65 Years
ALL
Yes
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Research Site
Glendale, California, United States
Research Site
Bridgeport, Connecticut, United States
Research Site
Danbury, Connecticut, United States
Research Site
Miami, Florida, United States
Research Site
Duncansville, Pennsylvania, United States
Research Site
Herston, Queensland, Australia
Research Site
Adelaide, South Australia, Australia
Research Site
Prahran, Victoria, Australia
Countries
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20101261
Identifier Type: -
Identifier Source: org_study_id
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