Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects
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ClinicalTrials.gov Identifier: NCT01258205 |
Recruitment Status :
Completed
First Posted : December 10, 2010
Last Update Posted : May 10, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Drug: AMG 139 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 48 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Actual Study Start Date : | February 28, 2011 |
Actual Primary Completion Date : | February 18, 2015 |
Actual Study Completion Date : | February 18, 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Part B
One dose level of AMG 139 administered as a multiple doses IV in subjects with mild-severe Crohn's disease.
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Drug: AMG 139
Four dose levels of AMG 139 administered as multiple doses IV or SC in healthy volunteers (Part A) and subjects with moderate-severe Crohn's disease (Part B). |
Experimental: Part A
Three dose levels of AMG 139 administered as a multiple doses IV or SC in healthy subjects.
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Drug: AMG 139
Four dose levels of AMG 139 administered as multiple doses IV or SC in healthy volunteers (Part A) and subjects with moderate-severe Crohn's disease (Part B). |
- Safety & tolerability: treatment-emergent AEs including clinically significant changes in physical examinations, safety lab tests, ECG, vital signs, or immunogenicity to AMG 139 [ Time Frame: 36 weeks ]
- Characterization of the pharmacokinetic (PK) parameters (AUCtau, Cmax, tmax) for AMG 139 after multiple IV and SC dose administrations in healthy subjects and subjects with mild to severe CD [ Time Frame: 36 weeks ]

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258205
United States, New Jersey | |
Comprehensive Clinical Research | |
Berlin, New Jersey, United States, 08009 | |
United States, New York | |
Stony Brook University Medical Center | |
Stony Brook, New York, United States, 11794 | |
United States, Oklahoma | |
Oklahoma Foundation for Digestive Research | |
Oklahoma City, Oklahoma, United States, 73102 | |
United States, Virginia | |
Virginia Commonwealth University | |
Richmond, Virginia, United States, 23291 | |
Australia, Queensland | |
QPharm Pty Limited | |
Herston, Queensland, Australia, 4029 | |
Australia, South Australia | |
Clinical Medical and Analytical eXellence CMAX | |
Adelaide, South Australia, Australia, 5000 | |
Australia, Victoria | |
Centre for Clinical Studies (Alfred) | |
Prahran, Victoria, Australia, 3181 |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT01258205 |
Other Study ID Numbers: |
20090519 |
First Posted: | December 10, 2010 Key Record Dates |
Last Update Posted: | May 10, 2021 |
Last Verified: | May 2021 |
Amgen AMG 139 Crohn's Disease |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |