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Submitted on July 11, 2005
Accepted on December 6, 2005
WinPharm Associates, San Ramon CA.; ConjuChem, Inc., Montréal, Québéc, Canada; Section of Endocrinology, Department of Medicine, University of Illinois at Chicago, Chicago IL
* To whom correspondence should be addressed. E-mail: Frohman{at}uic.edu.
Context: Therapeutic use of growth hormone-releasing hormone (GHRH) to enhance GH secretion is limited by its short duration of action.
Objective: To examine the pharmacokinetic profile, pharmacodynamic effects, and safety of CJC-1295, a long-acting GHRH analog.
Design: Two randomized, placebo-controlled, double-blind, ascending dose trials with durations of 28 and 49 days.
Setting: Two investigational sites.
Participants: Healthy subjects, ages 21 to 61 yr.
Interventions: sc administration of CJC-1295 or placebo in one of 4 ascending single doses in the first study and in 2 - 3 weekly or biweekly doses in the second study.
Main Outcome Measures: Peak concentrations and area under the curve (AUC) of GH and IGF-1; standard pharmacokinetic parameters for CJC-1295.
Results: After a single injection of CJC-1295, there were dose-dependent increases in mean plasma GH concentrations by 2-10 fold for 
6 days and in mean plasma IGF-1 concentrations by 1.5- to 3-fold for 9 - 11 days. The estimated half-life of CJC-1295 was 5.8 - 8.1 days. After multiple CJC-1295 doses, mean IGF-1 levels remained above baseline for up to 28 days. No serious adverse reactions were reported.
Conclusions: sc administration of CJC-1295 resulted in sustained, dose-dependent increases in GH and IGF-1 levels in healthy adults and was safe and relatively well-tolerated, particularly at doses of 30 µg/kg or 60 µg/kg. There was evidence of a cumulative effect after multiple doses. These data support the potential utility of CJC-1295 as a therapeutic agent.
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