PK Equivalence Study of ABP 501 and Humira®

• Research type

  Research Study

• Full title

  A Randomized, Single-Blind, Single-Dose, 3-Arm, Parallel-Group Study to Determine the Pharmacokinetic Equivalence of ABP 501 and Adalimumab (Humira®) in Healthy Adult Subjects.

• IRAS ID

  103683

• Contact name

  Ronnie Beboso

• Sponsor organisation

  ICON Development Solutions Ltd on behalf of Amgen Ltd

• Research summary

  This is a multicentre study involving up to 4 sites located in the USA and Europe. It is a randomised, single-blind, single-dose, 3-arm, parallel-group study in healthy volunteers. The purpose of the study is to assess the pharmacokinetic equivalence of the study drug compared with the marketed drug Humira© (adalimumab) which is currently licensed for the treatment of rheumatoid arthritis. Screening will be up to 28 days prior to dosing. It is expected that BKE will recruit 99 volunteers aged 18 to 45 years. On day 1 volunteers will be randomised to either the comparator or the study drug. They will be dosed on Day 1 and stay in the study unit for at least 24 hours afterwards for safety and pharmacokinetic assessments. They will be discharged on Day 2. Volunteers will make a further 17 visits for safety and pharmacokinetic assessments. Safety and tolerability will be be reviewed by the study data review team after the 30th volunteer has been dosed, and dosing of additional subjects can continue during this time. Volunteers will be involved in the study for approximately 91 days - this includes the 28 day screening period.

• REC name

  HSC REC B

• REC reference

  12/NI/0059

• Date of REC Opinion

  1 Jun 2012

• REC opinion

  Further Information Favourable Opinion