Phase 1 PK & Safety Study of GP2015 & Enbrel (EU) in Healthy Subjects

• Research type

  Research Study

• Full title

  A randomised, double-blind, two-way cross-over study to determine the pharamcokinetics and safety of GP2015 and Enbrel (EU-licenced) following a single subcutaneous injection in healthy subjects

• IRAS ID

  89015

• Contact name

  Joseph Chiesa

• Sponsor organisation

  Hexal AG/Sandoz Biopharmaceuticals

• Eudract number

  2011-003736-31

• Research summary

  This is a randomized two period Phase I study. Subjects will attend a screening visit 2 to 21 days before the dosing day, which is defined as Day 0. Eligible subjects will be resident in the clinical unit from the day before dosing (Day -1) until at least 24 hours post dose (Day 1). Subjects will be dosed with a single injection of 50 mg of GP2015 or Enbrel© administered under the skin in the morning on Day 0 of both periods I and II. At each period a group of the first six subjects will be dosed prior to the remainder of the other subjects (sentinel dose group). Of these six subjects, three will be randomized to receive GP2015 and three will be randomized to receive Enbrel©. Dosing of these six subjects will staggered such that two subjects will be dosed on one day. Following review of the safety data and providing there are no safety concerns, the next two subjects will be dosed at least 24 hours later. The remaining two subjects of the sentinel dose group will then be dosed at least 24 hours later following a further review of the safety data from the preceding subjects. The rest of the subjects will only be dosed after the Investigator has assessed the available safety data from the sentinel group and there is no obvious safety concern .Thereafter, the subjects will return to the clinical unit on an out-patient basis for scheduled assessments up to Day 18 in each period. There will be a wash-out period of at least 35 days between the two periods. A follow-up examination will be performed on Day 28 in the second treatment period to check for development of antibodies. The total individual study duration is up to 3 months.

• REC name

  East of England - Cambridgeshire and Hertfordshire Research Ethics Committee

• REC reference

  11/IE/0147

• Date of REC Opinion

  20 Oct 2011

• REC opinion

  Further Information Favourable Opinion