beanlicker
05-14-2013, 04:42 AM
Saw this posted on PM. Thought it was interesting.
PEGYLATED HGH
Multiple doses of pegylated long-acting growth hormone are well tolerated in healthy male volunteers and possess a potential once-weekly treatment profile.
Rasmussen MH, et al. Show al Clin Endocrinol (Oxf). 2010 Dec;73(6):769-76. doi: 10.1111/j.1365-2265.2010.03863.x Global Development, Novo Nordisk A/S, Novo Allé, Bagsvaerd, Denmark [email protected]
Abstract
OBJECTIVES:
Recombinant human growth hormone (rhGH) replacement therapy n children and adults currently requires daily subcutaneous injections for several years or lifelong. The current study examined safety tolerability, pharmacokinetic and pharmacodynamic response parameters after single and multiple doses of a long-acting rhGH preparation
DESIGN:
Randomized, double-blinded, placebo-controlled, multiple-dose, dose- escalating (0·02, 0·04, 0·08 and 0·16 mg protein (http://www.synthetek.com/products/synthepure-whey-protein-isolate/)/kg), sequential dose group trial
SUBJECTS:
Forty adult Japanese healthy male volunteers (a 20-45; body mass ndex: 18·0-27·0 kg/m(2)). Five groups (n = 8) were randomized to receive multiple doses of NNC126-0083 (n = 6) or placebo (n = 2)
METHODS:
NNC126-0083 compared with placebo. Blood samples for the assessment of pharmacokinetics (PK) and pharmacodynamics response [insulin-like growth factor I (IGF-I) and IGF binding protein 3 (IGFBP-3)] wer taken after multiple ascending doses. ascending doses.
RESULTS:
NNC126-0083 was well tolerated and not associated with any local injection-site reactions or lipoatrophy. Following administration, NNC126-0083 levels increased rapidly and remained elevated for several day returning to baseline before each weekly njection. Steady-state PK was achieved after the third dosing. A more than dose- proportional exposure was observed at the highest NNC126-0083 dose (0·16 mg prote kg). A strong dose-dependent pharmacodynamic response in circulating concentrations of both IGF-I and IGFBP-3 compared with placebo (P < 0·0001) was observed during the administration of al doses CONCLUSIONS: NNC126-0083 in healthy male volunteers ndicates that NNC126-0083 has the potentia for an efficacious, well-tolerated, once-weekly rhGH compound in the treatment of GH deficiency
PEGYLATED HGH IS THE 191AA SEQUENCE OF HGH WITH A POLY ETHYL GLYCOL MOLECULE BONDED TO IT TO INCREASE THE ACTIVE LIFE TO ONE WEEK.
PEGYLATED HGH
Multiple doses of pegylated long-acting growth hormone are well tolerated in healthy male volunteers and possess a potential once-weekly treatment profile.
Rasmussen MH, et al. Show al Clin Endocrinol (Oxf). 2010 Dec;73(6):769-76. doi: 10.1111/j.1365-2265.2010.03863.x Global Development, Novo Nordisk A/S, Novo Allé, Bagsvaerd, Denmark [email protected]
Abstract
OBJECTIVES:
Recombinant human growth hormone (rhGH) replacement therapy n children and adults currently requires daily subcutaneous injections for several years or lifelong. The current study examined safety tolerability, pharmacokinetic and pharmacodynamic response parameters after single and multiple doses of a long-acting rhGH preparation
DESIGN:
Randomized, double-blinded, placebo-controlled, multiple-dose, dose- escalating (0·02, 0·04, 0·08 and 0·16 mg protein (http://www.synthetek.com/products/synthepure-whey-protein-isolate/)/kg), sequential dose group trial
SUBJECTS:
Forty adult Japanese healthy male volunteers (a 20-45; body mass ndex: 18·0-27·0 kg/m(2)). Five groups (n = 8) were randomized to receive multiple doses of NNC126-0083 (n = 6) or placebo (n = 2)
METHODS:
NNC126-0083 compared with placebo. Blood samples for the assessment of pharmacokinetics (PK) and pharmacodynamics response [insulin-like growth factor I (IGF-I) and IGF binding protein 3 (IGFBP-3)] wer taken after multiple ascending doses. ascending doses.
RESULTS:
NNC126-0083 was well tolerated and not associated with any local injection-site reactions or lipoatrophy. Following administration, NNC126-0083 levels increased rapidly and remained elevated for several day returning to baseline before each weekly njection. Steady-state PK was achieved after the third dosing. A more than dose- proportional exposure was observed at the highest NNC126-0083 dose (0·16 mg prote kg). A strong dose-dependent pharmacodynamic response in circulating concentrations of both IGF-I and IGFBP-3 compared with placebo (P < 0·0001) was observed during the administration of al doses CONCLUSIONS: NNC126-0083 in healthy male volunteers ndicates that NNC126-0083 has the potentia for an efficacious, well-tolerated, once-weekly rhGH compound in the treatment of GH deficiency
PEGYLATED HGH IS THE 191AA SEQUENCE OF HGH WITH A POLY ETHYL GLYCOL MOLECULE BONDED TO IT TO INCREASE THE ACTIVE LIFE TO ONE WEEK.