Safety evaluation and toxicokinetics of repeated inhalation exposure to pegylated interferon α-2b.

ABSTRACT: This study aimed to evaluate the safety profile and toxicokinetic (TK) characteristics of pegylated interferon α-2b (PEG IFNα-2b) following repeated nebulized inhalation exposure in juvenile Sprague-Dawley (SD) rats, and to establish the no-observed-adverse-effect level (NOAEL) to support its clinical development for pediatric respiratory infections. A total of 190 juvenile SD rats (5-6 days old) were randomized into blank control, low- (126.4 ± 21.8 μg/kg), mid- (384.3 ± 66.9 μg/kg), and high-dose (1,202.4 ± 176.4 μg/kg) groups. Animals received nebulized PEG IFNα-2b via whole-body/nasal inhalation once every 2 days for two consecutive weeks. Assessments included clinical observations, body weight, hematology, coagulation, serum biochemistry, developmental parameters, histopatholog

SUBMITTER: Ji C 

PROVIDER: S-EPMC12739654 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature