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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
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).
Comprehensive Clinical Research
Berlin, New Jersey, United States
Stony Brook University Medical Center
Stony Brook, New York, United States
Oklahoma Foundation for Digestive Research
Oklahoma City, Oklahoma, United States
Virginia Commonwealth University
Richmond, Virginia, United States
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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QPharm Pty Limited
Herston, Queensland, Australia
Clinical Medical and Analytical eXellence CMAX
Adelaide, South Australia, Australia
Centre for Clinical Studies (Alfred)
Prahran, Victoria, Australia