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

Abstract

Purpose: 99mTc-DI-DD-3B6/22-80B3 (Thromboview, hereafter abbreviated to 99mTc-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 99mTc-DI-80B3 Fab′ in healthy volunteers. Methods: 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 99mTc-DI-80B3 Fab′. Safety outcomes (vital signs, electrocardiography, haematology, biochemistry, adverse events and development of human anti-human antibodies) wer..