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Galapagos and MorphoSys initiate Phase 1 study in joint antibody program MOR106

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Additional Relevant Details The primary objective of the Phase 1 study is to evaluate the safety and tolerability of single doses of MOR106. The study is randomized, double-blind, placebo-controlled and conducted in a single center in at least 56 healthy volunteers in Belgium, evaluating single ascending doses (SAD) administered as intravenous infusion. This Phase 1 study is characterized by its adaptive design, which enables the initiation of a subsequent multiple ascending dose (MAD) study in patients, depending on the outcome of the SAD study in healthy volunteers. The study’s secondary objective is to characterize the pharmacokinetic profile of MOR106 as well as monitor the occurrence of anti-drug antibodies as a measure of immunogenicity with MOR106. Topline results of the complete study, including the potential subsequent MAD part in patients, are expected in the second half of 2017.
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Occurred on:
Apr 07, 2016
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Related Keywords Mor106, Monoclonal Antibody, Joint Antibody Program