Safety and Anti-Inflammatory Effects of Engineered Extracellular Vesicles (ILB-202) for NF-κB Inhibition: A Double-Blind, Randomized, Placebo-Controlled Phase 1 Trial.

ABSTRACT: Excessive activation of NF-κB is implicated in the pathogenesis of numerous inflammatory and autoimmune diseases; however, conventional NF-κB inhibitors often cause widespread immunosuppression. In contrast, extracellular vesicles (EVs) are promising vehicles for therapeutic cargo delivery with advantages including reduced risk of replication. In this single-centre, randomized, double-blind, placebo-controlled phase 1 trial, we evaluated ILB-202, an engineered, allogeneic EV derived from HEK293 cells and loaded with a super-repressor IκBα. A single ascending intravenous dose of ILB-202 was administered to 18 healthy volunteers, and the short-term safety, tolerability, and preliminary pharmacodynamic effects were assessed. ILB-202 was well tolerated at all dose levels with no serious or dos

SUBMITTER: Hyun S 

PROVIDER: S-EPMC12465005 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature