• Title/Summary/Keyword: YHB216

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Study on Local Irritation in Rabbits and Micronucleus Test in Mice with YHB216 (YHB216의 토끼에서 국소독성시험 및 마우스에서 소핵시험)

  • 강민정;김미영;박명규;김봉태;안경규;최연식;문병석;이종욱
    • Toxicological Research
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    • v.18 no.1
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    • pp.79-85
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    • 2002
  • YHB216 is one of new recombinant human erythropoietins (rHu-EPO) developed by Yuhan Research Institute. The rHu-EPO products are widely being used for the treatment of various types of anemia. As a series of safety studies on YHB216, we performed the local irritation test (dermal & ocular application) in male New Zealand White rabbits and micronucleus test in male ICR mice. In the skin irritation test, 0.5 ml of YHB216 10,000 IU/ml solution was applied to the back skin of rabbits for 24 hours and sub-sequent observation was performed. There was no induced response after the treatment and the primary irritation index (P.I.I.) was‘0’. In the eye irritation test, 0.1 ml of YHB216 10,000 IU/mL solution was instilled into the conjunctiva of the eye. No treatment-related reaction was observed at the cornea, iris, and conjunctiva. In the micronucleus test, YHB216 was administered intravenously to male mice (6 mice per group) at dose levels of 0, 6,250, 12,500, and 25,000 IU/kg. Bone marrow cells were collected at 24 hours after the treatment. YHB216 treated groups showed no significant difference in the P/N (polychromatic erythrocyte/ normochromatic erythrocyte) ratio and in the number of micronucleated polychromatic erythrocyte com-pared with the control. In conclusion, YHB216 was found to be a non-irritating material up to 10,000 IU/ml in the local irritation test and to be a non-mutagen up to 25,000 IU/kg in the micronucleus test.

Intravenous Single Dose and Four-week Repented Dose Toxicity Study of YHB216, a Recombinant Human Erythropoietin, in Beagle Dogs (YHB216의 비글개에서 정맥내 단회 및 4주 반복투여독성시험)

  • 노용우;장호송;지형진;정은용;신지순;강민정;안경규;최연식;이종욱
    • Biomolecules & Therapeutics
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    • v.10 no.1
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    • pp.59-69
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    • 2002
  • Recently, recombinant human erythropoietin (rHu-EPO) has been used to treat various types of anemia. YHB216 is a new rHu-EPO developed by Yuhan Research Institute. In this study, we investigated the single dose and 4-week repeated dose toxicity of YHB216 in Beagle dogs. In the single dose toxicity study, YHB216 was administered intravenously at single dose levels of 0 and 25,000 IU/kg to dogs (2 dogs/sex/group). There were no treament-related changes in survivals, clinical signs, body weight gain, hematological values, blood chemical values, and necropsy finding during experimental period. In the repeated dose toxicity study, YHB216 was administered intravenously to dogs for 4 weeks at the dose levels of 0, 100, 500, and 2,500IU/kg (3 dogs/sex/group). There were no toxicologically significant changes in clinical signs, body weights, food and water consumptions, ophthalmoscopy, urinalysis and blood chemistry. There were increased values of red blood cell, hemoglobin, and hematocrit at all treated groups. Spleen revealed increased weight and extramedullary hematopoiesis at 500 IU/kg or more. These changes are all considered to be Pharmacology-related effects and were recovered after 4-week recovery period. From these results, it is concluded that LD50 value was above 25,000 IU/kg in the single dose toxicity study of YHB216 in dogs and the no observed adverse effect level (NOAEL) was 100 IU/kg day in the repeated dose toxicity study of YHB216 in dogs.

FOUR-WEEK INTRAVENOUS TOXICITY EVALUATION OF RECOMBINANT HUMAN ERYTHROPOIETIN, YHB216 IN BEAGLE DOGS

  • Sin, Ji-Soon;Jung, Eun-Yong;Zhang, Hu-Song;Huang, Zai-Zhi;Zheng, Mei-Shu;Kim, Dong-Kyu;Roh,Yong-Woo;Choi, Ehn-Kyung;Nam, Sang-Yoon;Kang, Jong-Koo
    • Proceedings of the Korean Society of Toxicology Conference
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    • 2001.10a
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    • pp.168-168
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    • 2001
  • To investigate the safety and toxicity of a recombinant human erythropoietin, YHB216, we performed 4-week repeated dose toxicity test in 4-month-old Beagle dogs. We injected intravenously everyday for 28 days with dosages of 0, 500, 2,500 and 12,500 I.U/kg body weight. There were not observed clinical signs or motality in the animals treated with YHB216. There were no significant changes in body weight, feed, or water consumption.(omitted)

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