Katty-Hind Selman-Housein B, Hernández BF, Abreu CÁA, Valenzuela SCM, Berlanga AJ, López SPA

Language: Spanish
References: 10
Page: 81-91
PDF size: 496.48 Kb.

ABSTRACT

Introduction: CIGB-500 is a synthetic peptide of 6 amino acids that was originally described as a potent stimulating agent for the secretion of the growth hormone and therefore called the growth hormone releasing peptide-6 (GHRP-6). In an experimental model of a myocardial infarct resulted in a safe reduction of the extension of the infarct. The present study was performed with the aim of determining its safety and tolerance, as well as assessing the pharmacokinetic and pharmacodynamic aspects of CIGB-500. Methods: A non-controlled, dose up scaling phase I clinical trial was performed in healthy volunteers. The product was administered in a single dose through the endovenous route in 6 dose levels: 1-10-50-100-200-400 µg/kg. The sample was formed by 18 apparently healthy men of between 18 and 35 years of age with a body weight within the normal limits and accepting to participate voluntarily in the study. In each scaling up dose level 3 individuals were treated and the progress towards the following level depended on the absence of toxicity. Results: The peptide CIGB-500 had an acceptable safety profile; the dosage was scaled up to the 6 levels. During the trial there were 23 adverse events (6 different events in 12 individuals); no serious adverse events reported. The peptide showed a bi-phasic concentration profile as a function of time, with a rapid distribution phase and a second phase that is slower. The administration of CIGB-500, under the experimental conditions studied; do not generate a harmful oxidative stress. Conclusions: The Growth Hormone-Releasing Peptide 6 was safe and tolerable under the conditions studied.

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