CinnaGen Medical Biotechnology Research Center, Alborz University of Medical Sciences , Karaj, Iran.
Biopharmaceutical Research Center, AryoGen Pharmed Inc., Alborz University of Medical Sciences , Karaj, Iran.
Expert Opin Investig Drugs. 2020 Dec;29(12):1443-1450. doi: 10.1080/13543784.2020.1831470. Epub 2020 Oct 12.
AryoTrust® (AryoGen Pharmed Co., Iran) is a biosimilar candidate for the EU-sourced reference trastuzumab, Herceptin®. This study was designed to evaluate the bioequivalence between AryoTrust® and Herceptin®.
In this double-blind, parallel study, 60 healthy male subjects were randomized 1:1 to receive a single dose of AryoTrust® or Herceptin® (6 mg/kg) as intravenous infusion. The primary endpoint of the study was the area under the concentration versus time to infinity (AUC), and the main secondary endpoints were maximum measured concentration (C), area under the concentration versus time from zero to the last quantifiable concentration time (AUC), immunogenicity, and safety.
Sixty subjects were enrolled in the study and baseline demographics were similar between the two groups. The two groups demonstrated similar pharmacokinetic parameters and the 90% confidence interval (CI) for primary and secondary endpoints were within the bioequivalence acceptance range (80.00%-125.00%). No serious adverse event or immunogenicity was reported, and all of the adverse events reported were mild and similar between the two treatment groups.
AryoTrust® was well tolerated, had a similar safety profile to reference trastuzumab, and its pharmacokinetic bioequivalence was confirmed.
The trial is registered at Indian Trials Registry (CTRI/2019/03/018218).
AryoTrust®（AryoGen Pharmed Co.，伊朗）是一种生物类似药候选药物，与欧盟来源的参照曲妥珠单抗（Herceptin®）具有相似性。本研究旨在评估 AryoTrust®与 Herceptin®之间的生物等效性。
在这项双盲、平行研究中，将 60 名健康男性受试者随机分为 1:1 组，分别接受单次静脉输注 AryoTrust®或 Herceptin®（6 mg/kg）。该研究的主要终点是浓度-时间曲线下面积至无穷大（AUC），主要次要终点是最大实测浓度（C）、浓度-时间曲线下从零到最后可量化浓度时间的面积（AUC）、免疫原性和安全性。
共有 60 名受试者入组该研究，两组间的基线人口统计学特征相似。两组的药代动力学参数相似，主要和次要终点的 90%置信区间（CI）均在生物等效性接受范围内（80.00%-125.00%）。未报告严重不良事件或免疫原性，且两组报告的所有不良事件均为轻度，且相似。
AryoTrust®耐受性良好，与参照曲妥珠单抗具有相似的安全性特征，其药代动力学生物等效性得到了证实。
该试验在印度临床试验注册中心（CTRI/2019/03/018218）注册。
