An open-label, single-dose bioavailability study of MLDL1278A

• Research type

  Research Study

• Full title

  An open-label, single-dose bioavailability study of MLDL1278A after subcutaneous and intravenous administration in healthy subjects

• IRAS ID

  88969

• Contact name

  Darren Wilbraham

• Sponsor organisation

  BioInvent International AB

• Eudract number

  2011-003569-14

• Research summary

  The drug being investigated in this study is MLDL1278A. MLDL1278A is an unlicensed drug being developed for the treatment of heart disease.Studies were done in rats, rabbits and monkeys, before investigating this drug in healthy humans and then in patients. To date 80 healthy subjects and more than 30 patients with stable heart disease have been given MLDL1278A or placebo. The drug has been well tolerated and a review of the data from the studies has not raised any safety concerns preventing administration of MLDL1278A to healthy subjects and patients in further clinical studies. This study will be divided into two parts. These are Treatment A and Treatment B involving a total of 22 healthy male or female volunteers.Each treatment regimen will begin with a screening assessment at the unit.Treatment A will involve 12 healthy male or female volunteers aged 18-55 years. There will be a total of 18 visits if they are assigned to this treatment regimen. Treatment A of this study will involve two admissions each of 3 days and 2 nights in the unit and there will be 15 outpatient visits also. These visits will occur over a 5 month period in total.Treatment B will involve 10 healthy male or female volunteers aged 18-55 years. There will be 10 visits in total if they are assigned to this treatment regimen.The study will start with Treatment B. Treatment B of this study will involve a single admission of 3 days and 2 nights in the unit. They will have to return to the unit for 8 outpatient visits the last being the final follow-up Day 71 post- dose.Treatment A may begin before all volunteers in Treatment B have been dosed.The study will take place at Quintiles Drug Research Unit.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  11/IE/0143

• Date of REC Opinion

  2 Nov 2011

• REC opinion

  Further Information Favourable Opinion