Multiple Ascending Doses of AMG 139 in Healthy and Crohn's Disease Subjects
Study identifier:20090519
ClinicalTrials.gov identifier:NCT01258205
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
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
Medical condition
Crohn’s disease
Phase
Phase 1
Healthy volunteers
Yes
Study drug
AMG 139
Sex
All
Actual Enrollment
48
Study type
Interventional
Age
18 Years - 55 Years
Date
Study Start Date: 28 Feb 2011
Primary Completion Date: 18 Feb 2015
Study Completion Date: 18 Feb 2015
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 May 2021 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Experimental: Part B One dose level of AMG 139 administered as a multiple doses IV in subjects with mild-severe Crohn’s disease. | 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. | 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). |
