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- Title
Pharmacokinetics and safety of roledumab, a novel human recombinant monoclonal anti-RhD antibody with an optimized Fc for improved engagement of FCγRIII, in healthy volunteers.
- Authors
Yver, A.; Homery, M.-C.; Fuseau, E.; Guemas, E.; Dhainaut, F.; Quagliaroli, D.; Beliard, R.; Prost, J.-F.
- Abstract
Background and Objectives A human recombinant monoclonal anti-RhD IgG may be useful to prevent RhD allo-immunization. Roledumab is such an antibody with a glycosylation pattern optimized for biological activity. The objective of the study was to assess the safety and pharmacokinetics of roledumab in healthy RhD-negative volunteers. Materials and Methods A total of 46 subjects received doses of 30-3000 μg i.v. of roledumab or placebo using a double-blind escalating single-dose design; 12 of these subjects also received 300 μg i.m. of roledumab. Subjects were followed for 6 months after administration. Serum roledumab concentrations were determined using flow cytometry. Results Fourteen treatment-emergent adverse events related to treatment were reported in nine subjects, with no apparent difference in their frequency or nature after placebo or roledumab administration. No anti-roledumab antibodies were detected. AUClast increased from 4·4 ng/ml.day at 30 μg i.v. to 2257 ng/ml.day at 3000 g i.v. The t½ ranged from 18 to 22 days, and the absolute bioavailability after i.m. administration was between 73% and 80%. Conclusion Roledumab is safe and well tolerated in healthy RhD-negative volunteers and shows a pharmacokinetic profile similar to that of polyclonal anti-RhD immunoglobulin.
- Subjects
PHARMACOKINETICS; CLINICAL trials; IMMUNOGLOBULINS; RECOMBINANT proteins; VOLUNTEERS' health; BIOAVAILABILITY; ERYTHROBLASTOSIS fetalis
- Publication
Vox Sanguinis, 2012, Vol 103, Issue 3, p213
- ISSN
0042-9007
- Publication type
Article
- DOI
10.1111/j.1423-0410.2012.01603.x