• Biomolecules & Therapeutics
• /
• v.6 no.4
• /
• pp.400-405
• /
• 1998

The pharmacokinetics of CJ-50001 (recombinant human granulocyte-colony stimulating factor, developed by R&D center of Cheil Jedang Corp.) were investigated in rats and dogs. The serum concentrations of CJ-50001 were measured by a sandwich enzyme immunoassay. After single intravenous (iv) administration of Cf-50001 to rats at a dose of 5 $\mu$g/kg, the mean terminal half-life and area under the concentration-time curve (AUC) were 0.96 h and 124.497g . h/ml, respectively. After single subcutaneous (sc) administration at the same dose, maximum serum concentration was observed at about 2 hours after administration, and the mean terminal half-life, AUC and the bioavailability were 1.11 h,63.58$\mu$g . h/ml and 51.07%, respectively. In repeated dosing studies, CJ-50001 was administered iv and sc to rats at a daily dose of 5$\mu$g/kg for 7 days. The pharmacokinetic parameters, such as mean AUC and terminal half-life, were no significantly different from those of single administration. Following single iv and sc administration of CJ-50001 to dogs at a dose of 5 $\mu$g/kg, mean AUCs were much higher than those of rats, due to the decreased clearence (CL). After sc administration to dogs, maximum serum concentration was observed at 2~4 hours after administration and the bioavailability was 54.60%.

• Biomolecules & Therapeutics
• /
• v.1 no.2
• /
• pp.270-274
• /
• 1993

The acute toxicity of a recombinant granulocyte-macrophage colony stimulating factor (code name: LBD-005) was evaluated in both sexes of ICR mice, 5~6 weeks old, by the oral, subcutaneous and intravenous routes of administration. Based on the results of the acute toxicity study, LBD-005 was not considered to induce any toxic effect on the mice in mortalities, clinical findings, body weights and gross findings. It is suggested that $LD_50$ values in mice would be >48 mg/kg in the oral route and >24 mg/kg in the subcutaneous or intravenous route.

• Toxicological Research
• /
• v.8 no.1
• /
• pp.17-27
• /
• 1992

Antigenicity of Recombinant Granulocyte macrophage colony stimulating factor(LBD-005), a newly developed drug for hematopoietic growth, was investigated in mice and guinea pigs. 1. Mice showed production of antibodies against LBD-005 (100mg/kg) with alumin]m hydroxide gel(alum) as an adjuvant, judged by the heterologous anaphylaxis(PCA) test using rats. On the other hand, antibodies against ovalbumin(OVA) inoculated with alum were definitely detected. 2. In the studies with guinea pigs, both the inoculation of LBD-005 only and of LBD-005 with complete Freund's adjuvant(CFA) as an adjuvant did not produce positive reactions in homologous passive cutaneous anaphylaxis (PCA).

• Toxicological Research
• /
• v.8 no.1
• /
• pp.49-61
• /
• 1992

Recombinant granulocyte-macrophage colony stimulating factor was subcutaneously administered to both sexes of Sprague-Dawley rats at the doses of 0, 0.5, 1 and 2mg/kg of body weight five days per week for 4 weeks to evaluate the subchronic toxicity. There were decreased 1 and 2 mg/kg. In the serum, changes were decreased alkaline phostatase(ALP) in the female groups dosed at 1 and 2mg/kg, and increased glutamic oxaloacetic transaminiase (GOT)in the male groups dosed at 0.5 and 2.0mg/kg.

• Toxicological Research
• /
• v.8 no.1
• /
• pp.41-48
• /
• 1992

The actue toxicity of a recombinant granulocyte macrophage colony-stimulating factor (code name: LBD-005) was evaluated in both sexes of Sprague-Dawley rats, 4 weeks old, by the oral, subcutaneous and intravenous routes of administration. LBD-005 in the acute toxicity study in the rats was not considerde to induce any toxicological effect on the rats in mortalities, clinical findings, body weights and gross findings. It is suggested that $LD_{50}$ values in rats would be >48 mg/kg in the oral route and >12 mg/kg in the subcutaneous or intravenous route.

• Toxicological Research
• /
• v.9 no.1
• /
• pp.61-67
• /
• 1993

LBD-005, a newly developed recombinant granulocyte-macrophage colony-stimulating factor, was at dose levels of 0, 20, 80 and 320ng/kg/day administered subcutaneously to pregnat New Zealand White rabbits during the organogenetic period. The dams were subjected to caesarean section on day 28 of pregnancy. Effects of test substance on dams and embryonal development of fetuses were examined. No treatment-related changes in clinical signs and necropsy findings of dams were observed in all groups. At 80 and 320 ng/kg, a significant decrease in food consumption followed by a loss in body weight was found.

• Biomolecules & Therapeutics
• /
• v.9 no.4
• /
• pp.311-317
• /
• 2001

YHB6211, a newly developed recombinant human granulocyte colonystimulating factor, was administered at dose levels of 0, 3, 15, and 75 $\mu$g/kg/day intravenously to the pregnant New Zealand White rabbits (20 rabbits per group) during the organogenetic period, days 6 to 18 of gestation. All dams were subjected to Caesarian section on day 28 of gestation and their fetuses were examined for external, visceral, and skeletal abnormalities. No abnormalities in clinical signs, body weight changes, gross findings, mortality, and external appearance were found in all dams and fetuses exposed to 0, 3, and 15 $\mu$g/kg/day of YHB6211. However, in the group treated with 75 $\mu\textrm{g}$/kg/day of YHB6211, maternal body and uterine weights, fetal body weights and length, and the number of live fetuses were significantly decreased and further fetal mortality was remarkably increased. It is suggested that YHB6211 may have no side effect up to the dose level of 15 $\mu$g/kg/day, and there would be no teratogenicity for fetuses of rabbits up to 75 $\mu\textrm{g}$/kg/day even if it may have some toxic effects over 75$\mu\textrm{g}$/kg/day for dams and fetuses of rabbits.

• Proceedings of the Korean Society of Developmental Biology Conference
• /
• 2005.10a
• /
• pp.130-130
• /
• 2005

• Proceedings of the Korean Society of Embryo Transfer Conference
• /
• 2005.10a
• /
• pp.130-130
• /
• 2005

• Toxicological Research
• /
• v.9 no.1
• /
• pp.69-72
• /
• 1993

LBD-005, a newly developed recombinant granulocyte-macrophage colony stimulating factor, was tested for primary skin irritation in male New Zealand White rabbits. In the primary skin irritation test, LBD-005 was applied to intact and abraded skins for 24 hours. Primary irritation index was "0" in test and control sites of all animals' thus LBD-005 was evaluated as a non-irritatant on the basis of the criteria of Draize et al. (1994).l. (1994).