PK equivalence study of a single IV dose of HD201 and Herceptin in HV

• Research type

  Research Study

• Full title

  A PHASE I, DOUBLE-BLIND, RANDOMISED, PARALLEL GROUP STUDY TO DEMONSTRATE THE EQUIVALENT PHARMACOKINETIC PROPERTIES OF A SINGLE INTRAVENOUS DOSE OF HD201 AND HERCEPTIN® IN HEALTHY MALE SUBJECTS

• IRAS ID

  111678

• Contact name

  Pui M Leung

• Sponsor organisation

  Hanwa Chemicals

• Eudract number

  2012-000805-56

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The purpose of this study is to demonstrate that the human body breaks down and processes the new drug HD201 in the same way as a marketed drug (Herceptin) in healthy male subjects. In addition, safety and tolerability of the new drug HD201 in comparison with the Herceptin safety and tolerability, will be assessed. This study will take place at ICON Development Solutions in Manchester. A total of 24 healthy male subjects aged 18 to 45 years, inclusive will be assigned at random to either the HD201 dose or the Herceptin dose. Neither the clinical staff, nor the volunteers will know which drug they will receive. This is the first administration of HD201 in humans.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  12/LO/1502

• Date of REC Opinion

  12 Oct 2012

• REC opinion

  Favourable Opinion