Pharmacokinetics, Pharmacodynamics, and Efficacy of a Novel Long-Acting Human Growth Hormone: Fc Fusion Protein
- Authors
- Kim, SJ[Kim, Su Jin]; Kwak, HH[Kwak, Hyun-Hee]; Cho, SY[Cho, Sung Yoon]; Sohn, YB[Sohn, Young Bae]; Park, SW[Park, Sung Won]; Huh, R[Huh, Rimm]; Kim, J[Kim, Jinsup]; Ko, AR[Ko, Ah-ra]; Jin, DK[Jin, Dong-Kyu]
- Issue Date
- Oct-2015
- Publisher
- AMER CHEMICAL SOC
- Keywords
- recombinant human growth hormone; Pc-domain of immunoglobulin G; pharmacokinetics; pharmacodynamics
- Citation
- MOLECULAR PHARMACEUTICS, v.12, no.10, pp.3759 - 3765
- Indexed
- SCIE
SCOPUS
- Journal Title
- MOLECULAR PHARMACEUTICS
- Volume
- 12
- Number
- 10
- Start Page
- 3759
- End Page
- 3765
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/42616
- DOI
- 10.1021/acs.molpharmaceut.5b00550
- ISSN
- 1543-8384
- Abstract
- The current recombinant human growth hormone (rhGH) therapy requires daily subcutaneous (sc) injections, which results in poor patient compliance, especially in young children. To reduce the dosing frequency, we generated a chimeric protein of rhGH and the Pc-domain of immunoglobulin G (IgG) (rhGH-Fc). The pharmacokinetics and pharmacodynamics of sc-injected rhGH-Fc were assessed in male Sprague-Dawley rats and hypophysectomized rats, respectively. A single sc injection of rhGH-Fc at a dose of 0.2 mg/kg slowly reached a C-max of 16.80 ng/mL and remained for 7 days with a half-life of 51.1 h. Conversely, a single sc injection of rhGH 0.2 mg/kg rapidly reached a C-max, of 46.88 ng/mL and declined with a half-life of 0.55 h to baseline values in 4 h. In the efficacy study, the sc-injected rhGH-Fc induced rapid weight gain and tibial width growth at a dose of 240 mu g/animal. The effect of two injections of rhGH-Fc separated by 1 week was comparable to that of the same dose of 14 daily injections of rhGH. The rhGH-Fc is a novel candidate for long-acting rhGH therapy with more convenient weekly administration, as it reduces glomerular filtration and receptor-mediated clearance while allowing for the rapid reversal of potential adverse events.
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Collections - Medicine > Department of Medicine > 1. Journal Articles
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