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
References
Sep 1, 1975·JAMA : the Journal of the American Medical Association·J Hirsh, A S Gallus
Feb 1, 1979·Archives of Internal Medicine·F W Blaisdell
Jun 1, 1992·Immunology and Cell Biology·F T LeeK Z Walker
Oct 1, 1991·Seminars in Nuclear Medicine·T F Schaible, A Alavi
Dec 15, 1991·Thrombosis Research·K Z WalkerP G Bundesen
Jan 1, 1990·European Journal of Nuclear Medicine·K Z WalkerG R Boniface
Jul 1, 1989·Seminars in Nuclear Medicine·P D KoblikH J Berger
Mar 1, 1985·Clinical Nuclear Medicine·R LisbonaC L Rush
Sep 15, 1983·Thrombosis Research·D B RylattA J Webber
Jun 1, 1994·Clinical Radiology·P L RobertsonM J Kelly
Apr 15, 1993·Journal of Neuroscience Research·S FeldblumA J Tobin
Dec 31, 1997·Circulation·T A MorrisK M Moser
Feb 18, 1998·JAMA : the Journal of the American Medical Association·J D DouketisJ S Ginsberg
Apr 1, 1998·Archives of Internal Medicine·M D SilversteinL J Melton
Oct 3, 1998·Annals of Internal Medicine·C KearonJ S Ginsberg
Mar 4, 1999·Angiology·M CiavolellaF Scopinaro
May 31, 2003·BMJ : British Medical Journal·Clive Tovey, Suzanne Wyatt
Jun 20, 2003·Circulation·Richard H White
Sep 5, 2003·Cancer Biotherapy & Radiopharmaceuticals·Erin McKay
Feb 14, 2004·American Journal of Respiratory and Critical Care Medicine·Timothy A MorrisMichael Gerometta
Jul 16, 2004·The New England Journal of Medicine·Shannon M Bates, Jeffrey S Ginsberg
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
Jun 5, 2012·Thrombosis Research·James D DouketisMike Gerometta
May 17, 2011·Heart, Lung & Circulation·Timothy A MorrisDavid Macfarlane
May 22, 2010·Journal of Virological Methods·J Hobson-PetersP Toye
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
Nov 8, 2008·Drugs in R&D·Laura C A PerryMatthew P Baker
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