Safety of the Drug Prospekta: a Preclinical Study of Acute and Repeated Dose Toxicity.

Autor: Kardash EV; Research Institute of General Pathology and Pathophysiology, Moscow, Russia. physactive@yandex.ru.; LLC 'MATERIA MEDICA HOLDING', Moscow, Russia. physactive@yandex.ru., Bugaeva LI; Volgograd State Medical University, Ministry of Health of the Russian Federation, Volgograd, Russia., Lebedeva SA; Volgograd State Medical University, Ministry of Health of the Russian Federation, Volgograd, Russia., Sundukova MS; State Research Center Institute of Immunology, Federal Medical-Biological Agency of Russia, Moscow, Russia., Tarasov SA; Research Institute of General Pathology and Pathophysiology, Moscow, Russia.; LLC 'MATERIA MEDICA HOLDING', Moscow, Russia.
Jazyk: angličtina
Zdroj: Bulletin of experimental biology and medicine [Bull Exp Biol Med] 2023 Dec; Vol. 176 (2), pp. 176-180. Date of Electronic Publication: 2024 Jan 08.
DOI: 10.1007/s10517-024-05990-8
Abstrakt: General toxic effect of the drug Prospekta (modified affinity purified antibodies to the brain-specific S100 protein) was studied on mature male and female mice and rats: acute toxicity with double intragastric and intraperitoneal administration of the maximum permissible doses at a 2-h interval, repeated dose toxicity with intragastric administration of the maximum permissible and close to therapeutic doses for 6 months. No lethal and toxic effects on animals were observed, including no toxic effects on vital systems, i.e., CNS and cardiovascular system, as well systems with the functions that may be temporarily disrupted (excretory and digestive systems). All the differences between animals of the experimental and control groups varied within the physiological range. It can be concluded that the drug produces no general toxic effect on laboratory animals.
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Databáze: MEDLINE