All issues > Volume 33(8); 1990

Original Article

J Korean Pediatr Soc. 1990;33(8):1104-1110. Published online August 31, 1990.

The Pharmacokinetics, Acute Biological Effects and Safety of Recombinant Human Growth Hormones.

Jong Jin Seo¹

¹Department of pediatrics. College of Medicine, Chungnam National University, Taejeon, Korea

Received: February 6, 1990;  Accepted: May 3, 1990.

Abstract

The pharmacokinetics, acute biological성fccts and safety of yeast-derived recombinant methionyl- hGH (LBD-003), the first biosynthetic hGH in Korea, were studied in 10 healthy young adults who were administered 8 IU/day intramuscularly for four consecutive days. 1) GH levels reached a mean (±SD) peak of 27.5±10.7 ng/ml at 3.4±0.8 hours following the first dose, and other pharmacokinetic parameters of LBD-003 were similar to those reported for pituitary hGH and other biosynthetic hGH. 2) Markedly significant rise of IGF-1 and free fatty acid were observed after LBD-003 administra- tion (p<0.0001), but fasting blood glucose and C-peptide concentrations were not changed signifi- cantly. 3) There was no local or systemic untoward reactions during the 5 day period of observation following the first dose of LBD-003. 4) No significant changes in hematologic features, urinalysis, acute phase reactants, indices of liver and kidney function, and electrocardiography were noted following the administration of LBD- 003. Antibodies to hGH were not detected on days 30 or 60. The results show that LBD-003 is safe in short term, well tolerated, has pharmacokinetic and biological properties similar to pituitary hGH and other biosynthetic hGH.

Keywords :Recombinant human growth hormone