Bioequivalence study of LB03002 manufactured from two production lines

• Research type

  Research Study

• Full title

  A Two-Sequence, Two-Period, Crossover Bioequivalence Study of LB03002 Manufactured from Two Different Manufacturing Production Lines in Healthy Male Adult Volunteers.

• IRAS ID

  105022

• Contact name

  Simon L Singer

• Sponsor organisation

  LG Life Sciences Ltd.

• Eudract number

  2012-001535-31

• ISRCTN Number

  xx

• Research summary

  This study has been designed to assess whether LB03002 manufactured from two different production lines (Production Line 1 and Production Line 2) is comparable in terms of quality and functionality. This study will take place at the ICON Development Solutions Clinical Pharmacology Unit in Manchester. Approx 60 healthy white european male subjects aged 35 -55 will participate in the study in five groups (cohorts) of 12. Volunteers are expected to complete the screening visit and two Treatment Periods separated by a minimum of a 21-days washout period. In each treatment period volunteers will receive a single subcutanous dose of LB03002, a sustained-release formulation of recombinant human growth hormone from one of the production lines (1 or 2). In each treatment period volunteers will also receive three doses of a somatostatin analogue - Octreotide. Both clinical research staff and the volunteers will be aware of which production line test product has been manufactured from.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  12/LO/0796

• Date of REC Opinion

  25 May 2012

• REC opinion

  Favourable Opinion