Crucell starts Rabies Phase I Antibody Cocktail Clinical Study in India
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Crucell N.V. announced that the rabies monoclonal antibody product it is developing has entered a Phase I clinical study in India, four months after launching a similar study in the US. Crucell has developed a human monoclonal antibody product for the post-exposure prophylaxis of rabies, using Crucell's MAbstract® and Crucell's PER.C6® technologies. This second Phase I study is closely linked to the initial Phase I study that is currently being performed in the US. Both studies are conducted under FDA authority, the Indian Phase I study gained approval upon review by the Drug Controller-General of India (DCGI).
The clinical trial will be a randomized, double-blind, placebo controlled study in 44 healthy volunteers that will test the antibody product alone in a dose escalation as well as in combination with rabies vaccine. The study, funded by Crucell, will be conducted through a clinical research organization in Mumbai, India. The main parameters under investigation will be safety, tolerability and (rabies virus) neutralizing activity.