A phase I, randomized, single-dose pharmacokinetic study comparing sb8 (bevacizumab biosimilar) with reference bevacizumab in healthy volunteers

被引:0
|
作者
Donghoon Shin
Yoon Jung Lee
Jihye Choi
Dahyoung Lee
Minjeong Park
Magdalena Petkova
机构
[1] Samsung Bioepis Co.,Medical Affairs
[2] Ltd,Clinical Development
[3] Samsung Bioepis Co.,Biometrics
[4] Ltd,Clinical Bioanalysis
[5] Samsung Bioepis Co.,Clinical Pharmacology Unit
[6] Ltd,undefined
[7] Samsung Bioepis Co.,undefined
[8] Ltd,undefined
[9] SGS LSS,undefined
来源
Cancer Chemotherapy and Pharmacology | 2020年 / 86卷
关键词
SB8; Bevacizumab; Biosimilar; Pharmacokinetics; Immunogenicity;
D O I
暂无
中图分类号
学科分类号
摘要
引用
收藏
页码:567 / 575
页数:8
相关论文
共 50 条
  • [21] Comparison of SB17 and reference ustekinumab in healthy adults: A randomized, double-blind, single-dose, phase I study
    Jeong, Hansol
    Kang, Taeseung
    Lee, Jiyoon
    Im, Seongsik
    INTERNATIONAL JOURNAL OF CLINICAL PHARMACOLOGY AND THERAPEUTICS, 2024, 62 (05) : 231 - 240
  • [22] A Randomized, Single-Dose, Parallel-Controlled Phase I Clinical Comparison of an Omalizumab Biosimilar Candidate with Reference Omalizumab in Healthy Chinese Male Volunteers
    Cheng, Jie
    Wang, Chenguang
    Xu, Jin
    Zhao, Chunyang
    Song, Rong
    Wang, Yijun
    Zou, Yang
    Zhang, Xunmin
    Shan, Yong
    Zhou, Jian
    Jia, Jing-Ying
    CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2024, 13 (04): : 349 - 359
  • [23] A randomized phase I pharmacokinetic study comparing SB4 and etanercept reference product (Enbrel®) in healthy subjects
    Lee, Yoon Jung
    Shin, Donghoon
    Kim, Youngdoe
    Kang, Jungwon
    Gauliard, Anke
    Fuhr, Rainard
    BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2016, 82 (01) : 64 - 73
  • [24] A Randomized, Double-Blind, Single-Dose Study Comparing the Biosimilarity of HOT-1010 With Bevacizumab (Avastin®) in Chinese Healthy Male Subjects
    Huang, Kai
    Que, Linling
    Ding, Ying
    Chu, Nannan
    Qian, Zhenzhong
    Shi, Yunfei
    Qin, Wei
    Li, Zhenni
    Chen, Yuanxin
    Gu, Xianghong
    Wang, Jiakun
    Zhang, Lin
    Zhang, Jisheng
    Zhu, Xiangyang
    Yang, Yongmin
    Tang, Yuan
    He, Qing
    FRONTIERS IN PHARMACOLOGY, 2021, 12
  • [25] A randomized, double-blind, single-dose study to evaluate the biosimilarity of QL1101 with bevacizumab in healthy male subjects
    Ya-nan Liu
    Jie Huang
    Can Guo
    Shuang Yang
    Ling Ye
    Shu-ting Wu
    Xing-fei Zhang
    Xiao-yan Yang
    Cui-cui Han
    Qi Pei
    Lu Huang
    Qing-nan He
    Guo-ping Yang
    Cancer Chemotherapy and Pharmacology, 2020, 85 : 555 - 562
  • [26] A randomized, double-blind, single-dose study to evaluate the biosimilarity of QL1101 with bevacizumab in healthy male subjects
    Liu, Ya-nan
    Huang, Jie
    Guo, Can
    Yang, Shuang
    Ye, Ling
    Wu, Shu-ting
    Zhang, Xing-fei
    Yang, Xiao-yan
    Han, Cui-cui
    Pei, Qi
    Huang, Lu
    He, Qing-nan
    Yang, Guo-ping
    CANCER CHEMOTHERAPY AND PHARMACOLOGY, 2020, 85 (03) : 555 - 562
  • [27] A Phase I Study Comparing PF-06439535 (A Potential Biosimilar) with Bevacizumab
    Knight, Beverly
    Rassam, Danielle
    Liao, Shanmei
    Meng, Xu
    Ewesuedo, Reginald
    JOURNAL OF THORACIC ONCOLOGY, 2015, 10 (09) : S548 - S548
  • [28] A randomized, double-blind, parallel-group, single-dose, pharmacokinetic bioequivalence study of INTP24 and bevacizumab in healthy adult men
    Singh, Inderjeet
    Patel, Ronak
    Patel, Akash
    Jose, Vinu
    CANCER CHEMOTHERAPY AND PHARMACOLOGY, 2020, 86 (02) : 193 - 202
  • [29] A phase III, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB8 (proposed bevacizumab biosimilar) and reference bevacizumab in patients with metastatic or recurrent nonsquamous non-small cell lung cancer
    Reck, Martin
    Luft, Alexander
    Bondarenko, Igor
    Shevnia, Serhii
    Trukhin, Dmytro
    Kovalenko, Nadezhda, V
    Vacharadze, Kakha
    Andrea, Fulop
    Hontsa, Anatoliy
    Choi, Jihye
    Shin, Donghoon
    LUNG CANCER, 2020, 146 : 12 - 18
  • [30] A randomized pharmacokinetic/pharmacodynamic study comparing the bioequivalence of potential biosimilar candidate P044 with reference medicine in healthy volunteers
    Raykova, Ekaterina
    Farahani, Mohammad Farmahini
    Ivanova, Stanislava
    Azhdarzadeh, Morteza
    EXPERT OPINION ON BIOLOGICAL THERAPY, 2022, 22 (02) : 235 - 243