Safety, pharmacokinetic and dosimetry evaluation of the proposed thrombus imaging agent 99mTc-DI-DD-3B6/22-80B3 Fab'

European Journal of Nuclear Medicine and Molecular Imaging
David MacfarlaneAndrew M Scott

Abstract

(99m)Tc-DI-DD-3B6/22-80B3 (Thromboview, hereafter abbreviated to (99m)Tc-DI-80B3 Fab') is a humanised, radiolabelled monoclonal antibody Fab' fragment with high affinity and specificity for the D-dimer domain of cross-linked fibrin. The purpose of this study was to evaluate the safety, pharmacokinetics and dosimetry of four increasing doses of (99m)Tc-DI-80B3 Fab' in healthy volunteers. Thirty-two healthy volunteers (18-70 years; 16 male, 16 female) received a single intravenous injection of 0.5, 1.0, 2.0 or 4.0 mg of (99m)Tc-DI-80B3 Fab'. Safety outcomes (vital signs, electrocardiography, haematology, biochemistry, adverse events and development of human anti-human antibodies) were assessed up to 30 days post injection. Blood and urine samples were collected up to 48 h post injection. Gamma camera images were acquired at 0.5, 1, 2, 4, 6 and 24 h post injection. Dosimetry was performed using standard MIRD methodology. No adverse events considered to be drug related were observed. Human anti-human antibody was not detectable in any subject during the follow-up period. (99m)Tc-DI-80B3 Fab' had a rapid initial plasma clearance (t (1/2)alpha=1 h). The pharmacokinetic profile of the Fab' fragment was generally linear across the four...Continue Reading

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Citations

Sep 19, 2008·European Journal of Nuclear Medicine and Molecular Imaging·David MacfarlaneAndrew M Scott
Mar 10, 2010·Journal of Thrombosis and Thrombolysis·Giuseppe LippiEmmanuel J Favaloro
Jan 7, 2011·Proceedings of the National Academy of Sciences of the United States of America·Jason R CantorGeorge Georgiou
Jun 18, 2011·American Journal of Respiratory and Critical Care Medicine·Timothy A MorrisJeffrey S Ginsberg
Sep 20, 2008·PLoS Pathogens·Amanda C StanleyChristian R Engwerda
May 17, 2011·Heart, Lung & Circulation·Timothy A MorrisDavid Macfarlane
Oct 6, 2010·Seminars in Nuclear Medicine·Timothy A Morris
Mar 6, 2015·Pathology Oncology Research : POR·L N Ramya, Krishna Kanth Pulicherla
Nov 30, 2016·Platelets·Marie-Cécile ValéraOlivier Lairez
Jun 14, 2017·Journal of Nuclear Cardiology : Official Publication of the American Society of Nuclear Cardiology·Gregory M LanzaXiaoxia Yang
Feb 27, 2013·British Journal of Clinical Pharmacology·Elizabeth TranterSteve Warrington

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