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Clinical and Morphological Aspects in Assessing the Safety of OSPL-502 with Repeated Dose Administration

Sergey A Zhuchkov1, Alexandr S Kinzirsky2, Irina V Koroleva2

  • 1Department of Histology, Cytology, and Embryology, Orel State University, Orel, Russia.

Open Access Macedonian Journal of Medical Sciences
|October 20, 2018
PubMed
Abstract

Insights

OSPL-502, a cognitive stimulant, showed minimal toxicity in rats. High doses affected the liver, kidneys, and adrenal glands, but these changes were reversible, indicating a favorable safety profile.

Area of Science:

  • Pharmacology
  • Toxicology
  • Drug Safety Evaluation

Background:

  • OSPL-502 is a novel drug candidate designed to enhance cognitive function.
  • Assessing the general toxic effects and identifying target organs of OSPL-502 is crucial for its clinical development.

Purpose of the Study:

  • To evaluate the clinical and histopathological changes induced by repeated administration of OSPL-502 in experimental animals.
  • To determine the dose-dependent toxicity and identify potential target organs of OSPL-502.

Main Methods:

  • The study followed OECD Guidelines (Test No. 407) using Sprague-Dawley rats.
  • OSPL-502 was administered at doses of 20, 60, and 180 mg/kg.
  • Clinical observations, body weight, food/water consumption, and histopathological examinations were conducted.

Main Results:

  • No adverse effects on body weight, consumption, musculoskeletal system, or exploratory behavior were observed at 20 and 60 mg/kg.
  • The 180 mg/kg dose exhibited mild clinical toxicity signs in female rats, without mortality.
  • Histostructural changes were noted in the liver, kidneys, and adrenal glands at the highest dose, which were reversible within 14 days post-treatment.

Conclusions:

  • OSPL-502 demonstrates a weakly pronounced toxic effect at 180 mg/kg, with 60 mg/kg as the threshold dose and 20 mg/kg as the no-observable-adverse-effect-level (NOAEL).
  • The liver, kidneys, and adrenal glands are identified as target organs for OSPL-502 toxicity.
  • The observed histopathological changes are reversible, suggesting a favorable safety profile for OSPL-502.
Keywords:
N,N’-substituted 3,7-diazabicyclo[3.3.1]nonanesOSPL-502Preclinical studiesSubchronic toxicityTarget organs

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