Classical Complement Inhibition By SAR445088 (BIVV020) in Adults with Cold Agglutinin Disease: Safety, Tolerability and Activity Results from the Open-Label, Non-Randomized, Single-Dose Phase 1b Study

被引:1
|
作者
D'Sa, Shirley [1 ]
Vos, Josephine M. I. [2 ,3 ]
Barcellini, Wilma [4 ]
Wardecki, Marek [5 ]
Perrin, Laurent [6 ]
Barker, Graham [7 ]
Zilberstein, Moshe [8 ]
Storek, Michael [9 ]
Chow, Timothy [9 ]
Roeth, Alexander [10 ]
机构
[1] Univ Coll London Hosp NHS Fdn Trust, Ctr Waldenstroms Macroglobulinemia & Related Cond, London, England
[2] Univ Amsterdam, Amsterdam UMC, Amsterdam, Netherlands
[3] Sanquin, Amsterdam, Netherlands
[4] Fdn IRCCS Ca Granda Osped Maggiore Policlin, Milan, Italy
[5] Sanofi, Warsaw, Poland
[6] Sanofi, Montpellier, France
[7] Sanofi, Chilly Mazarin, France
[8] Sanofi, Bridgewater, NJ USA
[9] Sanofi, Cambridge, MA USA
[10] Univ Duisburg Essen, Univ Hosp Essen, Dept Hematol & Stem Cell Transplantat, Essen, Germany
关键词
D O I
10.1182/blood-2023-177886
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
引用
收藏
页数:4
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    Jakate, Abhijeet
    Butler, Matthew
    Borbridge, Lisa
    Periclou, Antonia
    [J]. CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2021, 10 (07): : 726 - 733
  • [2] Single-Dose Pharmacokinetics and Safety of Ubrogepant in Adults With Hepatic Impairment: Results From an Open-Label, Phase 1 Trial
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    [J]. CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2022, 11 (07): : 857 - 864
  • [3] PHARMACOKINETICS AND TOLERABILITY OF A SINGLE DOSE OF APRAGLUTIDE IN SUBJECTS WITH NORMAL AND IMPAIRED RENAL FUNCTION: A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, PARALLELGROUP STUDY
    Greig, Gerard
    Hurley, Niamh
    Michel, Eric
    Youssef, Nader N.
    [J]. GASTROENTEROLOGY, 2022, 162 (07) : S654 - S654
  • [4] The Pharmacokinetics, Safety, and Tolerability of Rimegepant 75 mg are Similar in Elderly and Nonelderly Adults: a Phase 1, Open-Label, Parallel-Group, Single-Dose Study
    Croop, R.
    Stringfellow, J.
    Ivans, A.
    Coric, V
    [J]. HEADACHE, 2019, 59 : 177 - 178
  • [5] Rimegepant 75 mg Exposure, Safety, and Tolerability are Similar in Elderly and Nonelderly Adults: a Phase 1, Open-Label, Parallel-Group, Single-Dose Study
    Ivans, Andrea
    Stringfellow, Joseph
    Coric, Vlad
    Croop, Robert
    [J]. NEUROLOGY, 2020, 94 (15)
  • [6] Pharmacokinetics, Pharmacodynamics, and Tolerability of Olpasiran in Healthy Japanese and Non-Japanese Participants: Results from a Phase I, Single-dose, Open-label Study
    Sohn, Winnie
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    Neutel, Joel
    Wu, You
    Jabari, Freeman
    Terrio, Caitlin
    Varrieur, Tracy
    Wang, Jingying
    Hellawell, Jennifer
    [J]. CLINICAL THERAPEUTICS, 2022, 44 (09) : 1237 - 1247
  • [7] The Pharmacokinetics, Safety, and Tolerability of Rimegepant 75 mg Are Similar in Elderly and Nonelderly Adults: A Phase 1, Open-Label, Parallel-Group, Single-Dose Study
    Bhardwaj, Rajinder
    Morris, Beth
    Bertz, Richard
    Croop, Robert
    Liu, Jing
    [J]. CLINICAL PHARMACOLOGY IN DRUG DEVELOPMENT, 2024, 13 (01): : 37 - 44
  • [8] Rimegepant 75 mg Exposure, Safety, and Tolerability are Similar in Elderly and Nonelderly Adults: a Phase 1, Open-Label, Parallel-Group, Single-Dose Study
    Croop, Robert
    Stringfellow, Joseph
    Ivans, Andrea
    Coric, Vladimir
    [J]. CEPHALALGIA, 2019, 39 : 30 - 30
  • [9] Pharmacokinetics, pharmacodynamics, safety, and tolerability of a single-dose riliprubart, an anti-C1s humanized monoclonal antibody in East-Asian adults: results from a Phase 1, randomized, open-label trial
    Li, Yingxin
    Young Na, Joo
    Zhu, Yunting
    Oh, Jaeseong
    Zhao, Amy
    Jang, In-Jin
    Tang, Lei
    [J]. EXPERT OPINION ON INVESTIGATIONAL DRUGS, 2024,
  • [10] A PHASE 1, OPEN-LABEL, SINGLE-DOSE, NON-RANDOMIZED STUDY TO EVALUATE PHARM ACOKIN ETICS AND PHARM ACO DYNAMICS OF EDOXABAN IN PEDIATRIC PATIENTS.
    Zou, P.
    Zahir, H.
    Duggal, A.
    Pandya, G.
    Jin, J.
    Leil, T.
    [J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023, 113 : S100 - S100