Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Profiles of a Single-Dose JYB1904 in Healthy Chinese Participants: A Phase Ia, Randomized, Double-Blind, Placebo-Controlled Study.

ABSTRACT: Allergic asthma, characterized by airborne allergen sensitivity and Th2 immune responses, is a common and increasing global health concern. Omalizumab, while effective, has limitations such as weight- and IgE-dependent dosing regimens. JYB1904, a recombinant anti-IgE humanized monoclonal antibody (IgG1 subtype), showed superior preclinical properties. We performed a single-center, randomized, double-blind, placebo-controlled, single ascending-dose phase Ia trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of JYB1904 in healthy adult participants across five dose levels (range: 75-600 mg; subcutaneously). JYB1904 was well tolerated, with no serious adverse events or safety concerns beyond those observed with omalizumab. Immunogenici

SUBMITTER: Shen ZW 

PROVIDER: S-EPMC12160614 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature