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. 2023 Sep 5;13(10):2357–2373. doi: 10.1007/s13555-023-01010-1
Why carry out the study?
AK120 is a novel monoclonal antibody targeting interleukin 4 receptor alpha (IL-4Rα). The aim of this study was to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical preliminary efficacy of AK120 in both healthy subjects and subjects with moderate-to-severe atopic dermatitis (AD).
What was learned from the study?
AK120 was found to be safe and well tolerated in both healthy and AD subjects. There was no significant difference between the AK120 and placebo arms in terms of the incidence of treatment-emergent adverse events (TEAEs) and treatment-related TEAEs. There were no deaths nor treatment-related serious adverse events among the study cohorts.
The study provides preliminary efficacy results in the treatment of patients with AK120 by achieving improved Eczema Area and Severity Index (EASI) and Investigator Global Assessment (IGA) scores, which could be a reference for future studies of AK120.
This study provides the first evidence from a study involving humans that AK120 is safe and well tolerated in both healthy and AD subjects