Preclinical Studies into Specific Toxicity of a Candidate Drug Based on Complement C3 neodeterminant Recombinant Humanized Antibody for Treating Traumatic Brain Injuries
| Autor: | K. A. Nekrasova, A. V. Trofimov, A. V. Zhahov, S. V. Rodin, N. P. Gorbunov, A. V. Petrov, N. V. Pigareva, G. V. Alexandrov, M. S. Zakharov, A. S. Kiryanova, O. E. Khuttunen, I. V. Bendt, A. E. Krylova, A. M. Ischenko |
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| Rok vydání: | 2021 |
| Zdroj: | Journal Biomed. 17:68-80 |
| ISSN: | 2713-0428 2074-5982 |
| DOI: | 10.33647/2074-5982-17-4-68-80 |
| Popis: | This study aims to assess the specific toxicity (allergenicity, immunotoxicity and reproduction toxicity) of a dosage form of complement C3 neodeterminant recombinant humanized antibody. The reactions of general anaphylaxis, active cutaneous anaphylaxis and delayed-type reaction demonstrated no drug-related signs of experimental animal sensitization and immediate or delayed hypersensitivity in the treated animals. It was found that, in doses exceeding significantly the expected human therapeutic dose, the drug has no effect on humoral and cell-mediated immune responses. In addition, the drug does not suppress the phagocytic cell activity thereby indicating the absence of immunotoxic effect. Moreover, the drug has no adverse effects on male and female reproduction, progeny embryonal development, as well as prenatal and postnatal progeny development. The obtained data can be used in future clinical studies of the drug safety. |
| Databáze: | OpenAIRE |
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