Journal of the Korean Pediatric Society 1990;33(8):1104-1110.
Published online August 31, 1990.
The Pharmacokinetics, Acute Biological Effects and Safety of Recombinant Human Growth Hormones.
Jong Jin Seo
Department of pediatrics. College of Medicine, Chungnam National University, Taejeon, Korea
유전자 재조합 인간 성장호르몬의 약물동태, 생물학적 효과 및 안전성에 관한 연구
서종진
충남대학교 의과대학 소아과학교실
Received: 6 February 1990   • Accepted: 3 May 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.
Key Words: Recombinant human growth hormone




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