Study to Evaluate Two Formulations of AGN 214868

• Research type

  Research Study

• Full title

  A Phase 1, Single-center, Double-blind, Randomized, Parallel-group Study to Evaluate the Biocomparability of Two Formulations of AGN 214868 (Formulations a and ß) Administered as Intradermal Injections in Healthy Male Subjects

• IRAS ID

  76146

• Contact name

  Anthony Priestley

• Sponsor organisation

  Allergan Limited

• Eudract number

  2010‐024155‐82

• Research summary

  AGN-214868 manufacturing is being modified and as such the purpose of this is to evaluate the current AGN 214868 formulation (formulation a) with a new AGN 214868 formulation (formulation Ç?) when administered as 44 injections under the skin in healthy male subjects. It will also evaluate the repeat treatment safety of the AGN 214868 formulation Ç?. This will be the first administration in humans of AGN 214868 formulation Ç?. Each subject will undergo a screening visit, a 3 day and 3 night residential stay at the trial facility, 7 short visits to the trial facility for assessment and a follow up visit. Some subjects will undergo two treatment cycles. For these subjects the residential stay and visits to the trial facility will be performed twice. One injection will be made. Following 24 hours the remaining 43 injections will be made if there has been no injection site reaction. The two formulations will be compared by measuring the levels of the drug in the blood and the safety and immunogenicity. Ongoing safety assessments will be made throughout the study and observation of the injection sites will be made and recorded.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0039

• Date of REC Opinion

  5 Apr 2011

• REC opinion

  Further Information Favourable Opinion