Safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of subcutaneous and intravenous ALXN1720 in healthy volunteers: a phase 1, randomized, double-blind, placebocontrolled, single and multiple ascending dose study

被引:2
|
作者
Ortiz, Stephan [1 ]
McEneny, Alanna [1 ]
Amancha, Praveen [1 ]
Rice, Kara [1 ]
Scholz, Joachim [1 ]
Rakhade, Sanjay [1 ]
Yee, Min [1 ]
机构
[1] Alexion, AstraZeneca Rare Dis, Boston, MA USA
关键词
D O I
10.1212/WNL.0000000000203482
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
P1-5.016
引用
收藏
页数:3
相关论文
共 50 条
  • [1] Ascending Single Intravenous And Subcutaneous Dose Studies Of Benralizumab In Japanese Healthy Male Volunteers: Safety, Tolerability, Pharmacokinetics And Pharmacodynamics
    Saito, H.
    Yuji, W.
    Kawai, H.
    Nakanishi, T.
    AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE, 2015, 191
  • [2] Safety, tolerability, pharmacokinetics and pharmacodynamics of a single intravenous dose of SHR-1707 in healthy adult subjects: two randomized, double-blind, single-ascending-dose, phase 1 studies
    Yang, Yaru
    Qiu, Hongyan
    Fan, Yuru
    Zhang, Qin
    Qin, Huiling
    Wu, Juan
    Zhang, Xuan
    Liu, Yueyue
    Zhou, Renpeng
    Zhang, Qian
    Ye, Zi
    Ma, Jingyue
    Xu, Ye
    Feng, Sheng
    Fei, Yue
    Li, Na
    Cui, Xiaojing
    Dong, Fangli
    Wang, Quanren
    Shen, Kai
    Shakib, Sepehr
    Williams, Jasmine
    Hu, Wei
    ALZHEIMERS RESEARCH & THERAPY, 2024, 16 (01)
  • [3] Phase 1 Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AG-946 in Healthy Volunteers
    Merica, VarshaIyer Elizabeth
    Ronseaux, Sebastien
    Gamache, Tressa
    Mulrow, Nancy J.
    Belcijan, Anja
    Callaghan, Michael U.
    BLOOD, 2021, 138
  • [4] Vedolizumab Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability Following Administration of a Single, Ascending, Intravenous Dose to Healthy Volunteers
    Maria Rosario
    Timothy Wyant
    Timothy Leach
    Serap Sankoh
    Catherine Scholz
    Asit Parikh
    Irving Fox
    Brian G. Feagan
    Clinical Drug Investigation, 2016, 36 : 913 - 923
  • [5] Vedolizumab Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability Following Administration of a Single, Ascending, Intravenous Dose to Healthy Volunteers
    Rosario, Maria
    Wyant, Timothy
    Leach, Timothy
    Sankoh, Serap
    Scholz, Catherine
    Parikh, Asit
    Fox, Irving
    Feagan, Brian G.
    CLINICAL DRUG INVESTIGATION, 2016, 36 (11) : 913 - 923
  • [6] A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability After Subcutaneous Administration of Tozorakimab in Healthy Chinese Participants
    Li, Yunfei
    Zhang, Hua
    Pandya, Hitesh
    Miao, Liyan
    Reid, Fred
    Jimenez, Eulalia
    Sadiq, Muhammad Waqas
    Moate, Rachel
    Lei, Alejhandra
    Zhou, Xiao-Hong
    Kell, Chris
    Ding, Junjie
    Zhang, Guanlin
    Zhao, Lina
    Ge, Xiaoyun
    CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2024, 13 (06): : 665 - 671
  • [7] Pharmacokinetics, Pharmacodynamics, Safety, Tolerability, and Immunogenicity of the QX002N anti-IL-17 Monoclonal Antibody: A Phase I, Randomized, Double-Blind, Single Ascending Dose Study in Healthy Chinese Volunteers
    Wu, Min
    Zhang, Hong
    Li, Qianqian
    Chen, Hong
    Fang, Min
    Yang, Lizhi
    Ding, Yanhua
    FRONTIERS IN PHARMACOLOGY, 2022, 12
  • [8] A phase 1, single-center, randomized, double-blind, placebo controlled, single ascending dose study to investigate the safety, tolerability, and pharmacokinetics of intravenous and subcutaneous garadacimab (CSL312) in healthy subjects
    McKenzie, A.
    Roberts, A.
    Malandkar, S.
    Feuersenger, H.
    Panousis, C.
    Pawaskar, D.
    ALLERGY AND ASTHMA PROCEEDINGS, 2022, 43 (06) : 562 - 563
  • [9] Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alirocumab in Healthy Chinese Subjects: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study
    Haiyan Li
    Yudong Wei
    Zhenhua Yang
    Shuang Zhang
    Xiuxiu Xu
    Mengmeng Shuai
    Olivier Vitse
    Yiwen Wu
    Marie T. Baccara-Dinet
    Yi Zhang
    Jianyong Li
    American Journal of Cardiovascular Drugs, 2020, 20 : 489 - 503
  • [10] Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Alirocumab in Healthy Chinese Subjects: A Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study
    Li, Haiyan
    Wei, Yudong
    Yang, Zhenhua
    Zhang, Shuang
    Xu, Xiuxiu
    Shuai, Mengmeng
    Vitse, Olivier
    Wu, Yiwen
    Baccara-Dinet, Marie T.
    Zhang, Yi
    Li, Jianyong
    AMERICAN JOURNAL OF CARDIOVASCULAR DRUGS, 2020, 20 (05) : 489 - 503