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Pharmacokinetics and safety of recombinant anti-RhD in healthy RhD-negative male volunteers.

Author(s): Bichler J, Spycher MO, Amstutz HP, Andresen I, Gaede K, Miescher S

Affiliation(s): ZLB Bioplasma AG, Wankdorfstrasse 10, CH-Berne 22, Switzerland. johann.bichler@zlb.com

Publication date & source: 2004-04, Transfus Med., 14(2):165-71.

Publication type: Clinical Trial; Randomized Controlled Trial

In this first-in-man study, we assessed the pharmacokinetics, safety and tolerability of MonoRho, a human recombinant monoclonal anti-RhD immunoglobulin G1 (IgG1) antibody. Eighteen RhD-negative healthy male volunteers were randomized in two groups to receive a single administration of 300 micro g of MonoRho either intravenously or intramuscularly. There were no symptoms of allergic or anaphylactic type reaction in any subject, and there was no evidence of any MonoRho-related changes in laboratory safety parameters. None of the subjects mounted a detectable immune response to MonoRho. Serum samples were obtained up to 91 days after injection to measure anti-D IgG concentrations by flow cytometry. After intramuscular administration of MonoRho, anti-D IgG concentrations gradually increased reaching peak levels after a mean of 3.4 days. After 3 weeks, the mean anti-D IgG concentrations after intravenous and intramuscular administration became virtually equal to each other and remained so thereafter. In both the treatment groups, the mean elimination half-life was about 18 days and thus similar to that described for plasma-derived anti-D IgG. The bioavailability of MonoRho after intramuscular administration was estimated as 46%. The excellent tolerability and safety of MonoRho as well as its expected elimination half-life supports the continued clinical development of this compound.

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