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Crucell Announces Start of Rabies Antibody Product Clinical Trial

18 Dec 2006 - Crucell N.V. announced that the rabies monoclonal antibody product it is currently developing has entered a Phase I clinical study in the United States. Crucell has developed a human monoclonal antibody product, a combination of two monoclonal antibodies for the post-exposure prophylaxis (PEP) of rabies, using its MAbstract® and PER.C6® technology. The pre-clinical evaluation of the antibody product was performed in collaboration with the Rabies Program of the Centers for Disease Control and Prevention (CDC) in Atlanta.
 
The Crucell-funded US clinical trial will be a randomized, double-blind, placebo controlled study in 60 healthy volunteers that will test the antibody product alone in a dose escalation study as well as in combination with a rabies vaccine. The main parameters under investigation will be safety, tolerability and (rabies virus) neutralizing activity.