Dose Optimization of rhIL-7-hyFc for Patients With Lymphopenia Using a Neonatal Fc Receptor-Mediated Recycling-Based and Target-Mediated Drug Disposition Pharmacokinetic Model.

ABSTRACT: Recombinant human interleukin-7 hybrid Fc (rhIL-7-hyFc) is a homodimer of rhIL-7 fused to a hyFc. Exogenous IL-7 promotes T cell proliferation and increases lymphocyte count, making it a potential treatment option for lymphopenia and cancer. To improve therapeutic efficacy, rhIL-7-hyFc was developed as a long-acting IL-7. This study aimed to create a pharmacokinetic model for rhIL-7-hyFc by incorporating neonatal Fc receptor (FcRn)-mediated recycling and target-mediated drug disposition (TMDD) of the IL-7 receptor. Data were collected from a randomized, double-blind, placebo-controlled phase 1 trial involving 30 healthy volunteers who received single doses of rhIL-7-hyFc. Volunteers received 20 or 60 mg/kg subcutaneously, 60 mg/kg intramuscularly (IM), or a placebo. Clinical data were prov

SUBMITTER: Jeon HS 

PROVIDER: S-EPMC12094080 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature