AN OPEN‐LABELLED STUDY OF THE SAFETY, ACUTE METABOLIC ACTIVITY AND PHARMACOKINETIC PROFILE OF A SHORT‐TERM COURSE OF RECOMBINANT HUMAN GROWTH HORMONE IN HEALTHY VOLUNTEERS

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Abstract
The safety and short-term biological effects of recombinant human GH (Genotropon, KmbiVitrum AB, Stockholm, Sweden) given i.m. (8 IU/d) for 4 consecutive days to 10 healthy male volunteers, have been evaluated. No adverse reactions were detected by clinical investigation. Haematological parameters, clinical chemistry and the acute phase inflammatory profile showed no negative effects of the drug. The well-known metabolic effects of GH were seen an an increase in free fatty acids and in the somatomedin level (IGF-1). No antibodies to GH periplasmic Escherichia coli peptides developed during the first month after treatment. The peak plasma level of hGH (62 .+-. 20 mU/l) occurred between 3.0 and 3.5 h. This study shows that recombinant hGH induces no toxic or other adverse reactions and that the acute metabolic effects and the pharmacokinetic profiles are comparable to those reported after injections of GH extracted from pituitary glands.