Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects
Status: | Completed |
---|---|
Conditions: | Gastrointestinal, Crohns Disease |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 55 |
Updated: | 5/20/2017 |
Start Date: | February 28, 2011 |
End Date: | February 18, 2015 |
A Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease, and Pharmacodynamics of AMG 139 in Healthy Subjects and Subjects With Mild to Severe Crohn's Disease
The purpose of this study is to assess the safety and tolerability of AMG 139 following
multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and
in subjects with mild to severe Crohn's disease (CD).
multiple intravenous (IV) or subcutaneous (SC) dose administration in healthy subjects and
in subjects with mild to severe Crohn's disease (CD).
Inclusion Criteria:
Part A - Healthy Subjects:
- Healthy male or female of non-reproductive potential subjects between 18 to 45
years-of-age
- Body mass index (BMI) between 18 and 32 kg/m2
- Normal or clinically acceptable physical examination, clinical laboratory values, and
ECG
- Additional inclusion criteria apply
Part B - Crohn's Subjects:
- Male or female subjects with CD between 18 to 55 years-of-age
- Body mass index (BMI) between 18 and 32 kg/m2
- Normal or clinically acceptable physical examination (PE), clinical laboratory
values, and ECG; clinically acceptable PE includes evidence of mild to severe CD
- Diagnosis of ileal or ileo-colonic CD for a minimum of 6 months
- Mild to severe CD defined by a Crohn's Disease Activity Index (CDAI) score equal to
or greater than 180 and equal to or less than 450
- Elevated fecal calprotectin and CRP
- Additional inclusion criteria apply
Exclusion Criteria:
Parts A - Healthy Subjects:
- 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 evaluation, procedures or completion;
- Recent or on-going infection(s)
- Underlying condition(s) that predisposes the subject to infections
- History of malignancy of any type
- Additional exclusion criteria apply
Part B only - Crohn's Subjects:
- 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 evaluation, procedures or completion;
- Recent or on-going infection(s)
- Underlying condition(s) that predisposes the subject to infections
- History of malignancy of any type
- Additional exclusion criteria apply
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5
sites
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Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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Stony Brook University Medical Center Stony Brook Medicine expresses our shared mission of research, clinical...
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