A First-in-Human, Single- and Multiple-Dose Study of APG777, a Half-Life-Extended Anti-IL-13 Monoclonal Antibody, in Healthy Volunteers.

ABSTRACT: Interleukin (IL)-13 plays a central role in Type 2 inflammation, contributing to the pathogenesis of atopic dermatitis, asthma, and related inflammatory diseases. APG777 is a novel anti-IL-13 monoclonal antibody engineered for improved pharmacokinetics and reduced dosing frequency. This first-in-human, randomized, double-blind, placebo-controlled phase 1 study evaluated the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of single and multiple subcutaneous doses of APG777 in healthy adults. Forty participants were enrolled in single ascending dose (300-1200 mg) and multiple dose (300 mg × 2) cohorts. APG777 was well tolerated, with only mild-to-moderate treatment-emergent adverse events, predominantly unrelated to the study drug. No serious or severe drug-related treatment-e

SUBMITTER: Lim XQ 

PROVIDER: S-EPMC12718551 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature