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  • Title: A randomized, double-blind, parallel-group phase I study comparing the pharmacokinetics, safety, and immunogenicity of LY01008, a candidate bevacizumab biosimilar, with its reference product Avastin® in healthy Chinese male subjects.
    Author: Zhou R, Yang J, Liu Y, Zhang Q, Lu C, Tang K, Li X, Tang W, Gao E, Wu C, Dou C, Hu W.
    Journal: Expert Opin Biol Ther; 2022 Feb; 22(2):263-269. PubMed ID: 34913787.
    Abstract:
    BACKGROUND: Bevacizumab, an inhibitor of angiogenesis, has been approved in several anti-cancer therapies. This study compared the pharmacokinetic (PK) profiles, safety, and immunogenicity of a bevacizumab biosimilar, LY01008, with those of European Union - approved bevacizumab (Avastin®) in healthy Chinese males. RESEARCH DESIGN AND METHODS: In this double-blind, open-label, parallel-group study, healthy Chinese male subjects were randomized 1:1 to receive either LY01008 or Avastin® 3 mg/kg intravenously. Primary study endpoints were PK parameters such as the area under the concentration-time curve (AUC) from time zero to infinity (AUC0-∞), AUC from time zero to last quantifiable concentration (AUC0-t), and maximum serum concentration (Cmax). Secondary study endpoints included safety, tolerability, and immunogenicity. RESULTS: One hundred and twelve subjects were randomized to receive LY01008 (n = 56) or Avastin® (n = 56). The 90% CIs of the GMRs of AUC0-t, AUC0-∞, and Cmax of LY01008 to Avastin® were all within the bioequivalence margin. Other PK parameters, safety, and immunogenicity profiles were comparable across the two treatment groups. CONCLUSIONS: This study demonstrated equivalent PK, comparable safety, and similar immunogenicity of LY01008 to Avastin® in healthy subjects, thus paving the way for further clinical evaluation. TRIAL REGISTRATION: The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT05110118).
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