A Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of A140 Injection and Cetuximab (Erbitux®) in Healthy Chinese Male Subjects

• Published in: Advances in therapy Vol. 42; no. 6; pp. 2797 - 2807
• Main Authors: Xu, Jia, Ge, Junyou, Li, Yaling, Liu, Shulin, Li, Sicong, Si, Jing, Liu, Juncheng, Zhu, Xiaoxue, Ding, Yanhua
• Format: Journal Article
• Language: English
• Published: Cheshire Springer Healthcare 01.06.2025
• Subjects: Adult; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - immunology; Antibodies, Monoclonal, Humanized - pharmacokinetics; Antineoplastic Agents, Immunological - administration & dosage; Antineoplastic Agents, Immunological - adverse effects; Antineoplastic Agents, Immunological - immunology; Antineoplastic Agents, Immunological - pharmacokinetics; Area Under Curve; Asian People; Cardiology; Cetuximab - administration & dosage; Cetuximab - adverse effects; Cetuximab - immunology; Cetuximab - pharmacokinetics; China; Double-Blind Method; East Asian People; Endocrinology; Healthy Volunteers; Humans; Internal Medicine; Male; Medicine; Medicine & Public Health; Middle Aged; Oncology; Original Research; Pharmacology/Toxicology; Rheumatology; Therapeutic Equivalency; Young Adult; China; A140; Safety; Immunogenicity; Cetuximab; Pharmacokinetics

Introduction This study aimed to compare the pharmacokinetic (PK) profiles, safety, and immunogenicity of the proposed A140 with those of cetuximab (Erbitux ® ) in healthy Chinese male subjects. Methods We conducted a randomized, single-dose, double-blind, parallel-controlled phase I study in which...