Status:
COMPLETED
Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects
Lead Sponsor:
AstraZeneca
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 28 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2015
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01258205
Start Date
February 28 2011
End Date
February 18 2015
Last Update
May 10 2021
Active Locations (7)
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1
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
2
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
3
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States, 73102
4
Virginia Commonwealth University
Richmond, Virginia, United States, 23291