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Study Complete
Sponsor ID
20101261

Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 181.

Sponsor ID
20101261
Clinicaltrials.gov ID
NCT01290042
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

To assess the safety and tolerability of multiple subcutaneous doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.

Additional Study Details

Phase
Phase 1
Product
AMG 181
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
43
Additional Study Details

Protocol Summary

Primary Outcome Measures

To assess the number of adverse events per subject, after multiple subcutaneous doses of AMG 181 in in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.

Timeframe: 40 Weeks

Secondary Outcome Measures

To measure the area under the plasma concentration curve versus time of drug AMG 181.

Timeframe: 29 Weeks

To assess receptor saturation percentages relative to baseline after multiple doses of AMG 181.

Timeframe: 29 Weeks

To evaluate changes in peripheral blood T lymphocyte subsets counts relative to baseline after multiple doses of AMG 181.

Timeframe: 29 weeks

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Prahran, VIC, Australia, 3004
Status
Recruiting
Location
Research Site
Adelaide, SA, Australia, 5000
Status
Recruiting
Location
Research Site
Glendale, CA, United States, 91206
Status
Recruiting
Location
Research Site
Duncansville, PA, United States, 16635
Status
Completed
Location
Research Site
Danbury, CT, United States, 06810
Status
Completed
Location
Research Site
Bridgeport, CT, United States, 06606
Status
Completed
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Study Info
Age
18 - 65 Years
Condition
  • Ulcerative Colitis
    • Show more
  • Crohn's Disease
    • Sex
    All
    Trial Dates
    Feb 2011 - Apr 2014
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    - 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) - Additional inclusion criteria apply
    Exclusion Criteria:
    - 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) - Additional exclusion criteria apply