Pharmacokinetic properties of a 40 kDa branched polyethylene glycol‐modified form of consensus interferon‐α (PEG‐CIFN) in rhesus monkeys

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Abstract
The pharmacokinetic properties of a branched 40 kDa polyethylene glycol (PEG) conjugate formulation of consensus interferon‐α (CIFN) was evaluated in rhesus monkeys following subcutaneous administration. Four groups of rhesus monkeys (n=6 per group) received 1250, 300 and 150 µg/kg of PEG‐CIFN and 150 µg/kg CIFN, respectively. Serum concentrations of the interferons were measured with an antiviral activity assay at various time points after administration. The PK profiles of the pooled data were described by a noncompartmental method. Peak concentration of PEG‐CIFN was observed at 27–31 h, followed by a prolonged decay in comparison with the unmodified CIFN, the PEG‐CIFN had a 4–5‐fold longer terminal half‐life. The apparent clearance (dosesc/AUC) decreased from 150 mL/h/kg for CIFN to 19.0–45.5 mL/h/kg for PEG‐CIFNs. TheAUCwas lower for PEG‐CIFN than that for CIFN at the 150 µg/kg. Copyright © 2008 John Wiley & Sons, Ltd.