Double-Blind Randomized Phase I Study on the Clinical Tolerance and Pharmacodynamics of Natural and Recombinant Interferon-β Given Intravenously

The clinical tolerance and biological properties of 6 × 10⁶ IU of Chinese hamster glycosylated recombinant interferon-β (rHuIFN-β) and natural IFN-β (Frone) given i.v. were compared in 12 healthy volunteers in a randomized cross-over, double-blind trial. All subjects received a single injection of each type of IFN-β. Both were well tolerated and provoked similar changes in clinical indices. Serum neopterin (Np) values increased significantly from the 24th to 72nd h post-injection of rHuIFN-β and Frone. β2-Microglobulin (β2-M) serum levels were statistically above baseline 24–96 h after rHuIFN-β, and from the 24th to the 120th h with Frone. Both IFNs provoked a rise in intracellular 2′,5′-adenylate (2-5A) levels from the 10th to the 48th h, as well as in Hu-Mx synthesis, which was significant from the 10th to the 96th h. Serum levels of 2-5A, interleukin-1α (IL-1α), and interleukin-1β (IL-1β) remained unchanged. There were no statistical differences in the changes provoked by the two differently derived IFN-β in any of the biological parameters studied. Overall, the results of this study indicate that rHuIFN-β and Frone have similar pharmacodynamics.