A Phase 1, Randomized, Double-Blind, Single-Dose Comparative Pharmacokinetic Study Comparing SB17 (Proposed Ustekinumab Biosimilar) with Reference Ustekinumab in Healthy Subjects

被引：0
|
作者：
Jeong, Hansol [1 ]
Kang, Taeseung [1 ]
Lee, Jiyoon [1 ]
Im, Seongsik [2 ]
机构：
[1] Samsung Bioepis Co Ltd, Product Evaluat Team, Incheon, South Korea
[2] Samsung Bioepis Co Ltd, Qual Evaluat Team, Incheon, South Korea
来源：
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY | 2023年 / 89卷 / 03期
关键词：
D O I：
暂无
中图分类号：
R75 [皮肤病学与性病学];
学科分类号：
100206 ;
摘要：
41531
引用
收藏
页码：AB9 / AB9
页数：1
相关论文
共 50 条
  • [21] Pharmacokinetic Similarity of ABP 710, a Proposed Biosimilar to Infliximab: Results From a Randomized, Single-Blind, Single-Dose, Parallel-Group Study in Healthy Subjects
    Chow, Vincent
    Oh, MyungShin
    Gessner, Melissa A.
    Fanjiang, Gary
    [J]. CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2020, 9 (02): : 246 - 255
  • [22] A Phase I, Randomized, Double-Blind, Single-Dose, Placebo-Controlled Safety, Tolerability, And Pharmacokinetic/Pharmacodynamic Study Of Evolocumab In Healthy Chinese Subjects
    Liu, Chao
    Lu, Hong
    Yuan, Fei
    Chen, Wei-Li
    Xu, Hong-Rong
    Li, Hui
    Hsu, Cheng-Pang
    Egbuna, Ogo
    Wu, Jihua
    Dias, Clapton
    Abosaleem, Bassam
    Rana, Jitesh
    Monsalvo, Maria Laura
    Li, Xue-Ning
    Yu, Zhigang
    [J]. CLINICAL PHARMACOLOGY-ADVANCES AND APPLICATIONS, 2019, 11 : 145 - 153
  • [23] 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
    [J]. FRONTIERS IN PHARMACOLOGY, 2021, 12
  • [24] A randomized, single-blind, single-dose, parallel-group study in healthy subjects to demonstrate the pharmacokinetic equivalence of trastuzumab and its biosimilar
    Wang, Yanli
    Liu, Zhengzhi
    Deng, Qiaohuan
    Su, Zhengjie
    Xue, Jinling
    Zhao, Yicheng
    Yang, Haimiao
    [J]. EXPERT OPINION ON DRUG METABOLISM & TOXICOLOGY, 2023, 19 (11) : 849 - 855
  • [25] A randomized, single-blind, single-dose study to assess the pharmacokinetic equivalence of the biosimilar ABP 215 and bevacizumab in healthy Japanese male subjects
    Hanes, Vladimir
    Chow, Vincent
    Pan, Zhiying
    Markus, Richard
    [J]. CANCER CHEMOTHERAPY AND PHARMACOLOGY, 2018, 82 (05) : 899 - 905
  • [26] A randomized, single-blind, single-dose study to assess the pharmacokinetic equivalence of the biosimilar ABP 215 and bevacizumab in healthy Japanese male subjects
    Vladimir Hanes
    Vincent Chow
    Zhiying Pan
    Richard Markus
    [J]. Cancer Chemotherapy and Pharmacology, 2018, 82 : 899 - 905
  • [27] A randomized, double-blind, parallel-group, single-dose comparative pharmacokinetic study of DRL_TZ, a candidate biosimilar of trastuzumab, with Herceptin® (EU) in healthy adult males
    Lickliter, Jason D.
    Dadhania, Rakesh Naranbhai
    Trivedi, Ravi Kumar
    Kumar, S. R. Naveen
    Reddy, Pramod Kumar
    [J]. INDIAN JOURNAL OF MEDICAL RESEARCH, 2021, 154 (03) : 509 - 519
  • [28] PHARMACOKINETICS AND SAFETY OF CT-P47, A PROPOSED TOCILIZUMAB BIOSIMILAR, IN COMPARISON WITH EU-APPROVED TOCILIZUMAB; A PHASE 1, RANDOMIZED, DOUBLE-BLIND, TWO-ARM, SINGLE-DOSE STUDY IN HEALTHY SUBJECTS
    Yu, K. S.
    Kim, B.
    Shin, D.
    Park, M. K.
    Hwang, J. G.
    Kim, M.
    Chung, H.
    Ghim, J.
    Chung, J. Y.
    Smolen, J. S.
    Burmester, G. R.
    Kim, S. H.
    Bae, Y.
    Jeon, D.
    Yang, G.
    Yoo, J.
    Bae, J.
    Keystone, E.
    [J]. ANNALS OF THE RHEUMATIC DISEASES, 2023, 82 : 1385 - 1386
  • [29] Effects of formulation on the bioavailability of lutein and zeaxanthin: a randomized, double-blind, cross-over, comparative, single-dose study in healthy subjects
    Evans, Malkanthi
    Beck, Mareike
    Elliott, James
    Etheve, Stephane
    Roberts, Richard
    Schalch, Wolfgang
    [J]. EUROPEAN JOURNAL OF NUTRITION, 2013, 52 (04) : 1381 - 1391
  • [30] Effects of formulation on the bioavailability of lutein and zeaxanthin: a randomized, double-blind, cross-over, comparative, single-dose study in healthy subjects
    Malkanthi Evans
    Mareike Beck
    James Elliott
    Stephane Etheve
    Richard Roberts
    Wolfgang Schalch
    [J]. European Journal of Nutrition, 2013, 52 : 1381 - 1391
12345