Absorption, distribution, metabolism, and excretion of an antiviral drug-Fc conjugate CD388 following subcutaneous administration of 14C-CD388 in the rat

This study describes the ADME profile of CD388, a novel biologic combining a cyclised Fc fragment with dimeric Zanamivir (di-ZAN), for influenza prophylaxis. CD388, synthesized at Pharmaron incorporating 14C-labelled Zanamivir, was administered subcutaneously to rats. Total radioactivity and CD388 concentrations were measured in plasma and elimination routes were determined in excreta and bile. Images of the tissue distribution of radioactivity were prepared up to 35 days post-dose using QWBA, and tissue radioactivity concentrations were also determined.

Results indicated widespread tissue distribution and a plasma half-life of 210 hours. CD388 was the only circulating plasma species present with two metabolites containing unmodified dimeric Zanamivir present in urine.

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