Toxicological safety evaluation of ACM T1H by intravenously route in CENP: Beagle dogs

Abstract

Introduction: The humanized AcM T1h is an antibody produced by the Center of Molecular Immunology. This product is proposed for the treatment of Rheumatoid Arthritis. Objective(s): The objective of this study was to evaluate the toxicological safety of the repeated endovenous administration (12 weeks) of AcM T1h to Cenp: BEAG dogs. Material(s) and Method(s): We establish two experimental groups: control and treated (4X), of six animals each, 3 per sex. Measurements included clinical observations, body weight, rectal temperature, clinical signs (cardiac and respiratory frequencies, arterial pressure and pulse), electrocardiogram, ophthalmological evaluations, electrophysiological evaluations, neurological exams, and hematological and clinical chemistry. Result(s): The study ended with 100% survival. The results showed that body weight, body weight gains and rectal temperature were not affected by theAcMT1h. There were found significant differences between groups in cardiac and respiratory frequencies, but apparently not related with the test substance administration, since all values were found to be within those reported as normal for dogs. Hematological and serum chemistry was unaffected by the test substance. Conclusion(s): The results obtained showed that the AcM T1h is safe in the used biomodel.