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A Phase I Clinical Study, Randomized, Single-blind,Placebo-controlled, Multiple Doses, Dose Escalation Study fo the Safety, Tolerability and Pharmacokinetics of HX-1171 in Healthy Male Subjects.

This study is designed to multiple dose and dose escalation study

开始日期-

申办/合作机构

Biotoxtech Co., Ltd.

NCT01548391 / Unknown status临床1期

A Phase I Clinical Study Study of the Safety, Tolerability, and Pharmacokinetics of HX-1171 in Healthy Male Subjects

This study is designed to evaluate the safety, tolerability, and pharmacokinetics of HX-1171 in healthy male subjects.

开始日期2012-03-01

申办/合作机构

Biotoxtech Co., Ltd.

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项与 Biotoxtech Co., Ltd. 相关的文献（医药）

2022-06-01·Food Science and Biotechnology

Comparative sub-chronic toxicity studies in rats of two indistinguishable herbal plants, Cynanchum wilfordii (Maxim.) Hemsley and Cynanchum auriculatum Royle ex Wight

Article

作者: Kang, Jong-Koo ; Oh, Jae-Ho ; Lee, Jin Hee ; Kwon, HoonJeong ; Yu, Changwoo ; Hong, So-Hye ; Jeong, Jayoung ; Jung, Ki Kyung ; Yang, Jun-Young

AbstractSub-chronic toxicity studies using rats have been conducted for Cynanchum wilfordii (Maxim.) Hemsley (CW) and Cynanchum auriculatum Royle ex Wight (CA). CW water extract didn’t show any adverse effects whereas administering CW powder decreased body weights in complication with decreased food consumptions. In the case of CA water extract, triglyceride and absolute/relative liver weights were elevated and vacuolation was observed in liver. Treated CA powder in male rats increased alanine aminotransferase and aspartate aminotransferase and induced single cell necrosis and multinucleated hepatocyte in liver. As for female rats, increased absolute/relative weights and hypertrophy/vacuolation in adrenal glands and vacuolation in ovaries were observed when administered CA powder. In conclusion, no observed adverse effect level (NOAEL) of CW water extract was over 5000 mg/kg/day, while NOAEL of CW powder was 700 mg/kg/day for female and 150 mg/kg/day for male. In case of CA, NOAEL of water extract was 1500 mg/kg/day for male and 2000 mg/kg/day for female, while NOAEL of powder was 150 mg/kg/day for both gender. To the best of our knowledge, this is the first sub-chronic toxicity study on the adverse effects, target organs and its dose levels of C. wilfordii (Maxim.) Hemsley and C. auriculatum Royle ex Wight following GLP protocols.

2022-01-01·Intervirology

Rag2 Deficiency Enhances Susceptibility to Systemic Mouse Adenovirus Type 1 Infection

Article

作者: Lee, Han-Kyul ; Kim, Jun-Young ; Choi, Yang-Kyu ; Seo, Sun-Min ; Kim, Han-Woong ; Jeong, Eui-Suk

Introduction: Recombination-activating gene (Rag) 1 and Rag2, which are essential in V(D)J recombination, play a crucial role in B- and T-cell maturation. Method: We investigated the effects of Rag2 deficiency in clustered regularly interspaced short palindromic repeats/Cas9-mediated FVB-Rag2 knockout (KO) and wild-type (WT) mice infected with mouse adenovirus type 1 (MAV-1) via the intranasal route. Results: MAV-1 infection caused more severe histopathological changes in FVB-Rag2 KO mice than in WT mice. FVB-Rag2 KO mice exhibited moderate to severe inflammation on day 4 and severe inflammation on day 8 post infection. In contrast, WT mice showed mild inflammation on day 4 and mild to severe inflammation on day 8 post infection, including interstitial pneumonia and inflammatory cell infiltration in the lungs and liver. Viral loads in the spleen and kidneys were significantly higher in FVB-Rag2 KO mice than in WT mice on day 8 post infection. Levels of cytokines and chemokines, including macrophage inflammatory protein-1α, induced protein 10, interferon (IFN)-α, IFN-γ, and tumor necrosis factor alpha, were upregulated in the spleens of FVB-Rag2 KO mice compared with those of WT mice. The upregulation of several cytokines occurred concurrently with the histopathological changes. MAV-1 infection induced more severe systemic infection in FVB-Rag2 KO mice than in WT mice. Conclusion: In mice, Rag2 deficiency induces inflammatory cell recruitment via the upregulation of cytokine and chemokine levels. The MAV-1 infection model can be utilized to assess the efficacy and safety of therapeutic agents for human adenoviral diseases.

2020-01-01·Toxicological Research

Acute and 13-week subchronic toxicity studies of hot-water extract of Cynanchi wilfordii Radix in Sprague-Dawley rats

Article

作者: Moon, Seol-Hee ; Park, Sun-Hee ; Kang, Jong-Koo ; Han, Chung-Tack ; Lee, Hye-Yeong ; Bae, Heung-Mo ; Han, Kyoung-Goo ; Kim, Du-Yeol ; Nam, Chunja ; Kang, Sukmo ; Park, Cheol-Beom ; So, Jai-Hyun

Cynanchi wilfordii Radix (CWR) is a herbal medicinal plant that is well-known and used in Asian countries as a health food. In this study, acute and 13-week subchronic oral toxicity studies of hot-water extract of CWR (CWR-WE) were performed in Sprague-Dawley rats. For the acute toxicity study, CWR-WE was administered once orally to five male and five female rats at doses of 800, 2000, and 5000 mg/kg. Mortality, clinical signs, and body weight changes were monitored over 14 days. There were no treatment-related changes in these parameters and the approximate lethal dose of CWR-WE in male and female rats was determined to be > 5000 mg/kg. For the subchronic toxicity study, CWR-WE was administered orally once daily to male and female rats for 13 consecutive weeks at doses of 0 (vehicle control), 500, 1000, and 2000 mg/kg/day (n = 10 rats/sex/group). There were no toxicologically significant changes with regard to clinical signs, body weight, food consumption, ophthalmology, urinalysis, hematology, clinical chemistry, organ weights, necropsy findings, and histopathological findings. These results suggest that the oral no observed adverse-effect level of CWR-WE is > 2000 mg/kg/day for both sexes, although target organs were not identified.

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药物(靶点)	适应症	全球最高研发状态

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