PK, PD and dose response study of nasally administered hGH

• Research type

  Research Study

• Full title

  A single-centre, open-label, three-way crossover study in healthy volunteers to assess the dose response, pharmacokinetics and pharmacodynamics of nasally administered formulations of human growth hormone

• IRAS ID

  93948

• Contact name

  Pui Man Leung

• Sponsor organisation

  Critical Pharmaceuticals Limited

• Eudract number

  2011-005469-18

• ISRCTN Number

  1

• Research summary

  The purpose of this study is to investigate a new method for giving the drug human growth hormone (hGH), used for the treatment of growth hormone deficiency (GHD). hGH therapy is used to treat GHD in adults and children, as well as a range of other conditions. When treated with hGH, a child with GHD can begin to grow faster within months. Other benefits may also be noticed, such as increased strength, progress in movement development, and a reduction of body fat. hGH is currently administered by an injection under the skin (called Omnitrope). The injection devices used are designed to be as pain free as possible. However, repeated injections are often not well tolerated and can be a significant problem for some children. The drug being tested in this study, CP024-046B, is a nasally administered form of hGH. For patients with GHD, and in particular children with GHD, this will offer an alternative and more patient??friendly way for them to receive the hGH treatment. This study will look at how CP024-046B is handled by the body. That is, how fast the hGH gets into the blood after it has been administered to the nostrils and how quickly the body removes it again. We will also look at the effect of CP024-046B on the body; we will do this by measuring the levels of Insulin-like growth factor 1 (IGF-1) in the blood. IGF-1 is a hormone that is produced in response to increased levels of hGH. We will also be comparing CP024-046B against the standard treatment, Omnitrope. The safety of trial participants will be monitored by qualified and appropriately trained clinical staff throughout the study. Subjects will not be discharged from the study until they have satisfied the research physician that they are fit and well to do so.

• REC name

  Wales REC 2

• REC reference

  11/WA/0346

• Date of REC Opinion

  9 Dec 2011

• REC opinion

  Favourable Opinion