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KMID : 0385020020180010037
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Korean Journal of Laboratory Animal Science
2002 Volume.18 No. 1 p.37 ~ p.48
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Four-Week Repeated Dose Toxicity Study of a Novel Hepatitis B Virus-Immunotherapeutic Agent,MBRI-98304,in Rats and Beagle Dogs
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Abstract
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To investigate the repeated toxicity of MBRI-98304, a novel immunotherapeutic agent against hepatitis B virus (HBV), we performed 4-week repeated dose toxicity tests in Sprague-Dawley (SD) rats and Beagle dogs. MBRI-98304 was injected subcutaneously in rats and intramuscularly in dogs everyday for 28 days at doses of 5, 50, or 500㎍/㎏, respectively. No clinical signs or mortality were observed in animals treated with MBRI-98304 throughout the experimental period. Also, there were no significant changes in body weights, feed intake, water consumption, and any gross or histopathological lesions. Although, there were statistically-significant differences between the control and treated groups in urinalysis, relative and absolute organ weights, and hematological and biochemical analyses, the data were in biologically normal ranges and did not show a dose-dependent manner. Taken together, it is proposed that toxic dose levels of MBRI-98304 in both rats and dogs may be over 500㎍/㎏.
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KEYWORD
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