ArticlePharmaceutical research2025
Preclinical Toxicity Study and Tissue Distribution of YSCH- 01 Injection via Intratumoral Injection, Intravenous Injection, and Intraperitoneal Injection in Syrian Hamsters.
Article in Pharmaceutical research, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundRecombinant L-IFN Adenovirus (YSCH-01) is a modified oncolytic adenovirus, which showed good curative effects in a variety of solid tumors. The safety of YSCH-01 needs to be evaluated for non-clinical research.
methodsThis toxicity and distribution study of YSCH-01 injection via ITU/IV/IP injection in Syrian Hamster was conducted to prepare an investigational new drug (IND) application. The endpoints included mortality/moribundity, clinical observation, body weight, palpable mass examination, food consumption, ophthalmology, and clinical pathology. Toxicokinetics, ADA test, viral shedding, and tissue bio-distribution were analyzed.
resultsThe severely toxic dose in 10% of animals was 1 × 10
conclusionsOur study demonstrated the toxicity and potential toxicity of YSCH-01 in Syrian hamsters and evaluated its tissue distribution in hamsters after a single administration. STD10 results in hamsters support the safety of the estimated dosage for future clinical studies.
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