DOUBLE-BLIND RANDOMIZED PHASE-I STUDY ON THE CLINICAL TOLERANCE AND PHARMACODYNAMICS OF NATURAL AND RECOMBINANT INTERFERON-BETA GIVEN INTRAVENOUSLY

The clinical tolerance and biological properties of 6 x 10(6) IU of Ch inese hamster glycosylated recombinant interferon-beta (rHuIFN-beta) a nd natural IFN-beta (Frone) given i.v. were compared in 12 healthy vol unteers in a randomized cross-over, double-blind trial. All subjects r eceived a single injection of each type of IFN-beta. Both were well to lerated and provoked similar changes in clinical indices. Serum neopte rin (Np) values increased significantly from the 24th to 72nd h post-i njection of rHuIFN-beta and Frone. beta 2-Microglobulin (beta 2-M) ser um levels were statistically above baseline 24-96 h after rHuIFN-beta, and from the 24th to the 120th h with Frone. Both IFNs provoked a ris e 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-1 alpha (IL-1 al pha), and interleukin-1 beta (IL-1 beta) remained unchanged. There wer e no statistical differences in the changes provoked by the two differ ently derived IFN-beta in any of the biological parameters studied. Ov erall, the results of this study indicate that rHuIFN-beta and Frone h ave similar pharmacodynamics.