Blood levels and effects of SAR236553 given by injection, v1

• Research type

  Research Study

• Full title

  A randomized study of the relative bioavailability, pharmacodynamics, safety of SAR236553 (REGN727) after single subcutaneous administration at 3 different injection sites in healthy subjects (HMR code 12-025)

• IRAS ID

  120999

• Contact name

  Gary Peters

• Eudract number

  2012-005005-40

• Research summary

  The study medicine (SAR236553) is an experimental new medicine for treating people with high blood levels of a fatty substance called cholesterol. People with high blood cholesterol are at higher risk of heart disease and stroke. SAR236553 is a large protein called a ??monoclonal antibody??, which blocks a substance called PCSK9. Blocking PCSK9 helps the body clear cholesterol from the bloodstream. We'll compare blood levels of SAR236553 after injections in the upper arm, abdomen or thigh. We'll also assess the side effects of SAR236553 and its effects on blood levels of cholesterol and other fatty substances, and find out if participants make antibodies to SAR236553. We may also study how genes (pieces of DNA) and other substances affect how the body responds to or handles the study medicine. 60 healthy people, aged 18 to 45, will receive a single dose of study medicine, by injection under the skin, in the upper arm, abdomen or thigh. Participants will take up to 4 months to finish the study. They??ll stay on the ward for 2 nights and make 11 outpatient visits. A pharmaceutical company, Sanofi R&D, is funding the study. The study will take place at 1 centre in London. We'll recruit participants by: advertising; word of mouth; volunteer databases; and our websites.

• REC name

  Scotland A REC

• REC reference

  12/SS/0221

• Date of REC Opinion

  17 Dec 2012

• REC opinion

  Favourable Opinion