The purpose of this study is to assess the safety and tolerability of AMG 139 following single subcutaneous (SC) or intravenous (IV) dose administration in healthy subjects and subjects with moderate to severe psoriasis (PsO).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
73
Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers (Part A) and subjects with moderate-severe psoriasis (Part B).
Nucleus Network Limited
Melbourne, Victoria, Australia
Clinical Medical and Analytical eXcellence (CMAX)
Adelaide, Australia
QPharm Pty Limited
Herston, Australia
Auckland Clinical Studies Ltd
Grafton, New Zealand
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: 16-24 weeks
Characterization of the pharmacokinetics (PK) of AMG 139
Time frame: 16-24 weeks
Psoriasis Activity and Severity Index (PASI) scores (Part B only)
Time frame: 16-24 weeks
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