Healthy Volunteers Clinical Trial
Official title:
Generation of Biological Samples Positive to Somatropin for Anti-doping Control
Background:
Somatropin, also known as recombinant growth hormone (rhGH), is one of the World Anti-Doping
Agency (WADA) prohibited substances. Its consumption in athletes has been banned since 1990,
as it is known to improve physical performance.
Hypothesis:
The subcutaneous administration of recombinant somatropin (rhGH) in healthy subjects allows
obtaining positive doping samples.
The concentrations of hGH variants (isoforms) and biomarkers can be measured in serum.
Objectives:
Primary objective: To generate enough serum samples positive to recombinant somatropin in
order to be analyzed as control samples by anti-doping laboratories.
Secondary objective: To determine the analytical parameters necessary to detect the
administration of recombinant somatropin in healthy volunteers by direct and/or indirect
methods.
Methods:
Phase I, open, randomized clinical trial, with a treatment condition (recombinant somatropin
or rhGH) administered subcutaneously to 4 subjects (2:1 ratio). Control samples of the study
correspond to basal samples of 2 subjects who do not receive any treatment.
A blood sample volume of 450 mL is obtained from each subject receiving the treatment
condition to perform the proposed tests.
In order to validate the determination methodology of hGH variants and biomarkers, blood
samples from treatment group subjects are compared to reference blood samples of 450 mL from
a control group (not receiving treatment) as it is not possible to obtain a basal sample of
such volume from the subjects receiving treatment.
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