Tolerability and pharmacokinetics of TB-402 in healthy male volunteers

Clinical Therapeutics
Peter VerhammeM Jacquemin

Abstract

TB-402, a human monoclonal antibody that partially inhibits Factor VIII activity (FVIII:C), is being developed as a long-acting antithrombotic agent. The primary goal of this study was to investigate the tolerability of TB-402 in healthy male volunteers. Secondary objectives were to determine the pharmacokinetics and pharmacodynamics of TB-402. In this ascending-dose study, healthy subjects aged 18 to 45 years were randomly assigned in a 2:1 ratio to receive TB-402 administered as a single intravenous bolus at 0.015, 0.1, 0.5, 2.5, 12.5, 37.5, 188, 620, or 1860 microg/kg or matching inactive vehicle (placebo). An older group (55-75 years) was also administered the highest dose that was well tolerated in the younger group (1860 microg/kg). Adverse events (AEs) were obtained from spontaneous reporting and from answers to nonleading questions asked by the principal investigator and study staff during follow-up visits on days 4, 7 (+/-1 day), 14 (+/-1 day), 21 (+/-2 days), 28 (+/-3 days), 42 (+/-3 days), and 56 (+/-3 days) after TB-402 administration. AEs were monitored up to the last study visit on day 56 after the administration of TB-402 or placebo, with special attention to bleeding events. The pharma-codynamic assessment of TB...Continue Reading

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Citations

Jun 7, 2013·Thrombosis and Haemostasis·Maurits L van Montfoort, Joost C M Meijers
Jul 24, 2013·Expert Opinion on Investigational Drugs·Gentian Denas, Vittorio Pengo
Mar 1, 2011·Expert Opinion on Emerging Drugs·Gentian Denas, Vittorio Pengo
May 17, 2013·Thrombosis and Haemostasis·Francesco Dentali, Nicoletta Riva
May 1, 2012·Journal of Thrombosis and Haemostasis : JTH·M TangelderP Verhamme
Feb 27, 2013·British Journal of Clinical Pharmacology·Elizabeth TranterSteve Warrington
Jul 23, 2011·Thrombosis Research·J EmmerechtsP Verhamme
Nov 4, 2010·Therapeutic Advances in Cardiovascular Disease·Antonio Gómez-OutesEmilio Vargas-Castrillón
Sep 28, 2017·Expert Opinion on Drug Discovery·Antonio Gómez-OutesMª Luisa Suárez-Gea
Apr 4, 2017·Biomolecules & Therapeutics·Joo Hee KimHye Sun Gwak
Oct 26, 2018·Expert Opinion on Pharmacotherapy·Orsolya SzékelyGregory Yoke Hong Lip
Dec 12, 2017·Expert Opinion on Investigational Drugs·Gerasimos DimitropoulosGregory Y H Lip
Mar 7, 2020·Nature Reviews. Drug Discovery·Nigel MackmanJeffrey I Weitz

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