Safety, tolerability, PK & PD of 2 dose levels of ACP-001 (QBR113643)

• Research type

  Research Study

• Full title

  A Phase I, Single Dose, Randomised, Double-Blind, Placebo Controlled, Parallel Group Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of 2 Different Dose Levels of ACP-001 Administered Once in Healthy Volunteers

• IRAS ID

  105722

• Contact name

  Joanne Collier

• Sponsor organisation

  Ascendis Pharma A/S

• Eudract number

  2012-001727-13

• Research summary

  The Sponsor is developing a product with which is intended to meet current medical needs for a human growth hormone (hGH) deficiency treatment that is efficient in promoting growth and can be administered less often than currently available hGH treatments, which consist of a daily injection under the skin. It is hoped this will boost compliance. This study is testing the study drug ACP-001, a new hGH product with a unique, once-a-week dosing schedule. It has a similar active ingredient to an already approved hGH product. The study involves administering the drug in order to explore its safety, tolerability, pharmacokinetic (how the drug is broken down and absorbed by the body) and pharmcodynamic (how the drug affects the body) profiles.

• REC name

  HSC REC B

• REC reference

  12/NI/0074

• Date of REC Opinion

  22 May 2012

• REC opinion

  Further Information Favourable Opinion