Pharmacokinetics, Pharmacodynamics, and Safety of Subcutaneous and Intravenous Garadacimab Following Single-Dose Administration in Healthy Japanese and White Adults.

Autor: Glassman F; CSL Behring LLC, King of Prussia, Pennsylvania, USA., Lawo JP; CSL Innovation GmbH, Marburg, Germany., Bica MA; CSL Innovation GmbH, Marburg, Germany., Roberts A; CSL Innovation Pty Ltd, Parkville, Victoria, Australia., Pawaskar D; Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA., Akama H; CSL Behring, Tokyo, Japan., Jain M; Akero Therapeutics, South San Francisco, California, USA., Goodson S; EMD Serono, Inc., Rockland, Massachusetts, USA.

Publikováno v: Journal of clinical pharmacology [J Clin Pharmacol] 2024 Nov 24. Date of Electronic Publication: 2024 Nov 24.

Tento výsledek nelze pro nepřihlášené uživatele zobrazit.
K zobrazení výsledku je třeba se přihlásit.

Efficacy and safety of garadacimab, a factor XIIa inhibitor for hereditary angioedema prevention (VANGUARD): a global, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

Autor: Craig TJ; Allergy, Asthma and Immunology, Department of Medicine and Pediatrics, Penn State University, Hershey, PA, USA. Electronic address: tcraig@pennstatehealth.psu.edu., Reshef A; Allergy, Immunology & Angioedema Center, Barzilai University Hospital, Ashkelon, Israel., Li HH; Institute for Asthma and Allergy, Chevy Chase, MD, USA., Jacobs JS; Allergy & Asthma Clinical Research, Walnut Creek, CA, USA., Bernstein JA; University of Cincinnati, Department of Internal Medicine Division of Rheumatology, Allergy and Immunology and the Bernstein Clinical Research Center Cincinnati, Cincinnati, OH, USA., Farkas H; Department of Internal Medicine and Haematology, Hungarian Angioedema Center of Reference and Excellence, Semmelweis University, Budapest, Hungary., Yang WH; Ottawa Allergy Research Corporation, Department of Medicine, University of Ottawa, Ottawa, ON, Canada., Stroes ESG; Department of Vascular Medicine, Amsterdam UMC, Amsterdam, Netherlands., Ohsawa I; Department of Nephrology, Saiyu Soka Hospital, Saitama, Japan., Tachdjian R; Division of Allergy & Clinical Immunology, David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA, USA., Manning ME; Allergy, Asthma & Immunology Associates, Ltd, Internal Medicine, UA College of Medicine, Phoenix, Phoenix, AZ, USA., Lumry WR; AARA Research Center, Dallas, TX, USA., Saguer IM; HZRM Haemophilia Center Rhein Main, Mörfelden-Walldorf, Germany., Aygören-Pürsün E; Klinikum der Johann Wolfgang-Goethe Universität, Klinik für Kinder- und Jugendmedizin, Frankfurt, Germany., Ritchie B; Division of Hematology, Department of Medicine, University of Alberta, Edmonton, AB, Canada., Sussman GL; Gordon Sussman Clinical Research Inc and Department of Clinical Immunology and Allergy, St Michael's Hospital, Toronto, ON, Canada., Anderson J; AllerVie Clinical Research, Birmingham, AL, USA., Kawahata K; St Marianna University School of Medicine, Kawasaki-shi, Kanagawa, Japan., Suzuki Y; Department of Nephrology, Juntendo University Faculty of Medicine, Tokyo, Japan., Staubach P; Department of Dermatology and Allergy, University Medical Center, Mainz, Germany., Treudler R; University Leipzig Medical Faculty, Department of Dermatology, Venereology and Allergology, Leipzig Interdisciplinary Center for Allergology-CAC, Leipzig, Germany., Feuersenger H; CSL Behring Innovation GmbH, Marburg, Germany., Glassman F; CSL Behring, King of Prussia, PA, USA., Jacobs I; CSL Behring, King of Prussia, PA, USA., Magerl M; Institute of Allergology, Charité-Universitätsmedizin Berlin, Corporate Member of Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Frauhofer Institute for Translational Medicine and Pharmacology ITMP, Immunology and Allergology, Berlin, Germany.

Publikováno v: Lancet (London, England) [Lancet] 2023 Apr 01; Vol. 401 (10382), pp. 1079-1090. Date of Electronic Publication: 2023 Feb 28.

Systemic IgG exposure and safety in patients with primary immunodeficiency: a randomized crossover study comparing a novel investigational wearable infusor versus the Crono pump.

Autor: Wasserman RL; Allergy Partners of North Texas Research, 7777 Forest Lane, Suite B-332, Dallas, TX 75230, USA., Cunningham-Rundles C; Division of Clinical Immunology, Department of Medicine, Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, New York, NY 10029, USA.; Department of Pediatrics, Icahn School of Medicine at Mount Sinai, 1425 Madison Avenue, New York, NY 10029, USA., Anderson J; Clinical Research Center of Alabama (a division of AllerVie Health), 504 Brookwood Blvd Suite 250, Birmingham, AL 35209, USA., Lugar P; Departments of Medicine & Pediatrics, Division of Pulmonary, Allergy & Critical Medicine; Duke University Medical Center, Durham, NC 27705, USA., Palumbo M; Allergy & Clinical Immunology Associates, 180 Fort Couch Road, Pittsburgh PA 15241, USA., Patel NC; Children's Healthcare of Atlanta, Division of Pulmonary, Allergy/Immunology, Cystic Fibrosis, & Sleep, Emory University School of Medicine, 1400 Tullie RD NE, Atlanta, GA 30329, USA., Hofmann J; CSL Behring AG, Wankdorfstrasse 10, 3014, Bern, Switzerland., Glassman F; CSL Behring LLC, 1020 First Avenue, King of Prussia, PA 19406, USA., Rogers E; Enable Injections, Inc., 2863 E. Sharon Rd Cincinnati, OH 45241, USA., Praus M; CSL Behring Innovation GmbH, Emil-von-Behring-Straße 76, 35041, Marburg, Germany., Rojavin MA; CSL Behring LLC, 1020 First Avenue, King of Prussia, PA 19406, USA.

Publikováno v: Immunotherapy [Immunotherapy] 2022 Nov; Vol. 14 (16), pp. 1315-1328. Date of Electronic Publication: 2022 Sep 21.

Pharmacokinetic/pharmacodynamic modeling for dose selection for the first-in-human trial of the activated Factor XII inhibitor garadacimab (CSL312).

Autor: Pawaskar D; CSL Behring, King of Prussia, Pennsylvania, USA., Chen X; Genentech, San Francisco, California, USA., Glassman F; CSL Behring, King of Prussia, Pennsylvania, USA., May F; CSL Behring Innovation GmbH, Marburg, Germany., Roberts A; CSL Limited, Parkville, Victoria, Australia., Biondo M; CSL Limited, Parkville, Victoria, Australia., McKenzie A; CSL Limited, Parkville, Victoria, Australia., Nolte MW; CSL Behring Innovation GmbH, Marburg, Germany., Jusko WJ; School of Pharmacy and Pharmaceutical Sciences, University at Buffalo, Buffalo, New York, USA., Tortorici M; CSL Behring, King of Prussia, Pennsylvania, USA.

Publikováno v: Clinical and translational science [Clin Transl Sci] 2022 Mar; Vol. 15 (3), pp. 709-720. Date of Electronic Publication: 2021 Dec 08.