Study on the safety pharmacology of a novel anticancer drug: rhCNB for injection
LI Xue-hong
ZHANG Xiao-dian
TIAN Shu-hong
LI E
LIU Ying
TAN Peng
FU Jian
Abstract：Objective: To observe the effects of rhCNB on the cardiovascular and respiratory systems of cynomolgus monkeys and central nervous system of mice, and investigate the possible pharmacological effects of the drug on human safety, thus to provide evidence for clinical trials. Methods: KM mice were given a single dose of rhCNB of 12, 36 and 108 mg·kg-1 by intravenous injection. Autonomic activities, balance ability and cooperative sleep experiments were carried out to observe the effects of the drug on the central nervous system and animal behavior changes. Cynomolgus monkeys were given a single dose of rhCNB of 8. 2, 24. 6 and 73. 8 mg·kg-1 by injection through caudal vein. A non-invasive telemetry system was used to observe the heart rate, ECG, blood pressure, respiratory rate and body temperature. The effects of the drug on the cardiovascular system and respiratory system of cynomolgus monkeys were evaluated. Results: KM mice had no change in locomotor activity and motor coordination capacity after receiving rhCNB at all the dosags, and no collaborative sleep effect was observed with lower dose of pentobarbital sodium. No obvious dose-or animal aging-related cardiovascular and respiratory effects were observed in cynomolgus monkeys. Conclusion: rhCNB for injection has no significant effects on the centralnervous system, cardiovascular system and respiratory system of the experimental animals.
Keywords：recombinant human calcineurin B subunitcynomolgus monkeysEmka PACK4G animal noninvasive physiological signal telemetry systemcentral nervous systemcardiovascular systemrespiratory system
Publication Date：2018-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 1781-1786 )