QBR106712

• Research type

  Research Study

• Full title

  A SINGLE CENTRE, OPEN LABEL, FIVE WAY CROSSOVER STUDY IN HEALTHY VOLUNTEERS TO ASSESS THE PHARMACOKINETICS, PHARMACODYNAMICS AND TOLERABILITY OF NASALLY ADMINISTERED FORMULATIONS OF HUMAN GROWTH HORMONE

• IRAS ID

  71217

• Contact name

  Sharan Sidhu

• Sponsor organisation

  Critical Pharmaceuticals Limited

• Eudract number

  2010-023416-14

• Research summary

  The study will investigate the absorption of human growth hormone (hGH) in 2 CriticalSorb- powder formulations through the nose compared to a reference injected formulation, Omnitrope©, a placebo formulation of CriticalSorb-, and a nasal formulation of hGH without CriticalSorb-.Growth hormone (GH) is a protein-based peptide hormone. It stimulates growth, cell reproduction and regeneration in humans and other animals. Growth hormone is a 191-amino acid, single-chain polypeptide which is made, stored, and secreted by the somatotroph cells within the anterior pituitary gland (in the brain). Somatotropin refers to the growth hormone produced natively and naturally in animals, whereas the term somatropin refers to growth hormone produced by recombinant DNA technology, and is abbreviated "hGH" in humans.CP024 (the project code of the nasal hGH product) is being developed as a once-daily nasal formulation of somatropin (recombinant human growth hormone). It uses Critical Pharmaceuticals proprietary nasal drug delivery technology.Somatropin is not usually absorbed through the nasal membran's. However Critical Pharmaceuticals proprietary Criticalsorb-formulations improve absorption of somatropin and thereby make it possible to deliver the drug through the nose; greatly improving the ease of use for the patient compared to current treatments of daily injection.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/IEC01/29

• Date of REC Opinion

  2 Mar 2011

• REC opinion

  Further Information Favourable Opinion