CODEN: IJPNL6 HAEMATOLOGICAL EFFECTS AND SAFETY BEHAVIOUR OF 20 kDa PEGINTERFERON ALPHA-2A (UNIPEG®) IN HEALTHY HUMAN SUBJECTS

20 kDa pegylated interferon alpha-2a (UNIPEG®) manufactured through the pegylation of E.coli-derived interferon alpha-2a. The hematological effects of Unipeg® were studied after a single subcutaneous dose of 180 μg (protein content) in ten healthy human subjects. Vital signs, adverse events and lab tests (hematological and biochemical) were monitored for safety analysis. Clinical laboratory tests results before and after drug administration were processed for any statistically significant change by computing the ANOVA (F-value) and performing t-tests. Statistically significant decrease in neutrophils, absolute neutrophil count, total white blood cells count and platelets count were observed but most of these were not clinically significant. Transient leucopenia and leucopenia was reported for 10% and 20% subjects, respectively, transient thrombocytopenia in 10% subjects and an increase in ALT levels above normal ranges in 30% of subjects were observed while no serious adverse effect was reported. The hematological effects were found similar to those of reported in literature for unmodified IFN-alpha-2a and other pegylated IFN-alpha-2a products generally used in therapy.