Am. Liberati et al., DOUBLE-BLIND RANDOMIZED PHASE-I STUDY ON THE CLINICAL TOLERANCE AND PHARMACODYNAMICS OF NATURAL AND RECOMBINANT INTERFERON-BETA GIVEN INTRAVENOUSLY, Journal of interferon research, 14(2), 1994, pp. 61-69
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.