Study identifier:20090519
ClinicalTrials.gov identifier:NCT01258205
EudraCT identifier:N/A
CTIS identifier:N/A
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
Crohn’s disease
Phase 1
Yes
AMG 139
All
48
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 May 2021 by AstraZeneca
AstraZeneca
-
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).
Location
Location
Prahran, VIC, Australia, 3181
Location
Adelaide, SA, Australia, 5000
Location
Oklahoma City, OK, United States, 73102
Location
Berlin, NJ, United States, 08009
Location
Richmond, VA, United States, 23291
Location
Stony Brook, NY, United States, 11794
Location
Herston, QLD, Australia, 4029
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). |
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