QX008N, an Anti-TSLP Monoclonal Antibody: Pharmacokinetics, Tolerability, and Immunogenicity in Healthy Chinese Subjects.

ABSTRACT: QX008N, a humanized IgG1 monoclonal antibody against thymic stromal lymphopoietin (TSLP) with Fc engineering to extend half-life, was developed with the aim of exploring whether its extended half-life and cost-effective production could potentially address unmet needs in severe asthma therapy, such as the need for less frequent dosing and improved accessibility. This first-in-human, phase I trial evaluated pharmacokinetics (PK), tolerability, and immunogenicity of QX008N in healthy Chinese subjects following subcutaneous (SC) and intravenous (IV) administration. SC group dosing demonstrated dose-proportional exposure; for the 280 mg and 560 mg SC doses, AUC₀-∞ values were 37,611 and 81,450 h·μg/mL, respectively, with delayed Tmax (5-8 days) and absolute bioavailability of 62%-67%. Followin

SUBMITTER: Shen ZW 

PROVIDER: S-EPMC12947250 | biostudies-literature | 2026 Mar

REPOSITORIES: biostudies-literature