title: Double-blind randomized phase I study on the clinical tolerance and pharmacodynamics of natural and recombinant interferon-beta given intravenously.
abstract: The clinical tolerance and biological properties of 6 x 10(6) IU of Chinese hamster glycosylated recombinant interferon-beta (rHuIFN-beta) and natural IFN-beta (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-beta. 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-beta and Frone. beta 2-Microglobulin (beta 2-M) serum 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 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-1 alpha (IL-1 alpha), and interleukin-1 beta (IL-1 beta) remained unchanged. There were no statistical differences in the changes provoked by the two differently derived IFN-beta in any of the biological parameters studied. Overall, the results of this study indicate that rHuIFN-beta and Frone have similar pharmacodynamics.
authors.affiliation: Istituto di Clinica Medica Ia, Università di Perugia, Italy.
authors.forename: A M
authors.initials: AM
authors.lastname: Liberati
authors.forename: P
authors.initials: P
authors.lastname: Garofani
authors.forename: V
authors.initials: V
authors.lastname: De Angelis
authors.forename: F
authors.initials: F
authors.lastname: Di Clemente
authors.forename: M
authors.initials: M
authors.lastname: Horisberger
authors.forename: M
authors.initials: M
authors.lastname: Cecchini
authors.forename: A R
authors.initials: AR
authors.lastname: Betti
authors.forename: L
authors.initials: L
authors.lastname: Palmisano
authors.forename: S
authors.initials: S
authors.lastname: Astolfi
authors.forename: A
authors.initials: A
authors.lastname: Nastari
mesh_terms: D015088:2',5'-Oligoadenylate Synthetase / Q000097:blood; D000328:Adult; D000998:Antiviral Agents / Q000032:analysis; D001708:Biopterins / Q000031:analogs & derivatives / Q000097:blood; D004311:Double-Blind Method; D019204:GTP-Binding Proteins; D006801:Humans; D007275:Injections, Intravenous; D016899:Interferon-beta / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D007378:Interleukins / Q000097:blood; D008297:Male; D064547:Myxovirus Resistance Proteins; D019798:Neopterin; D011506:Proteins / Q000032:analysis; D011994:Recombinant Proteins / Q000008:administration & dosage* / Q000009:adverse effects / Q000494:pharmacology*; D001613:beta 2-Microglobulin / Q000032:analysis
chemical_list: D000998:Antiviral Agents; D007378:Interleukins; D064547:Myxovirus Resistance Proteins; D011506:Proteins; D011994:Recombinant Proteins; D001613:beta 2-Microglobulin; D001708:Biopterins; D019798:Neopterin; D016899:Interferon-beta; D015088:2',5'-Oligoadenylate Synthetase; D019204:GTP-Binding Proteins