Safety and Tolerability of BR38 in healthy volunteers (phase 1 study)

• Research type

  Research Study

• Full title

  Single-centre, single-blind, placebo-controlled phase I study with ascending single intravenous doses of BR38 to determine its safety and tolerability as contrast agent for echography in healthy volunteers

• Contact name

  Roxy Senior

• Sponsor organisation

  Bracco Imaging S.p.A

• Eudract number

  2007-005130-36

• ISRCTN Number

  N/A

• Research summary

  An ultrasound scan (without contrast agent) is a routine, very safe and widely used diagnostic procedure involving the use of high-frequency sound waves to create images of organs (for example heart or liver) within the body. The use of contrast agents in ultrasound scans allows better visualisation of the blood flow and explores small blood vessels which are not visible without contrast agent. These contrast-enhanced ultrasound scans are routinely used for better visualisation of the borders of the heart cavity, as well as the small blood vessels which bring nutrition to the heart, inside the heart muscles. It is also used to detect liver disease. The purpose of the study is to assess safety and tolerability of BR38 administered for the first time in humans. Some assessments will also be performed to assess the usefulness of the contrast agent on heart and liver. The study product (BR38) is a new generation contrast agent which was developed by Bracco Research, Geneva, Switzerland, for ultrasound imaging. It is a suspension containing millions of microbubbles smaller than red blood cells. BR38 does not contain protein or any animal bio products. The microbubbles can resist arterial pressure (inside the blood vessels) and remain in the blood. This property allows the ultrasound evaluation of the smallest vessels of organs, such as heart or liver, which are not visible without contrast, helping to determine the presence/absence of disease. This is the first time that BR38 will be administered to humans. The doses to be used in this study are based on the safety and imaging studies in animal species. The lowest dose to be tested is based on the largest no effect dose obtained in these studies divided by 200. The higher dose to be tested in the study was chosen based on the range of effective imaging for BR38 observed in animals for heart and liver; it is still much lower than the largest dose with no effect in these animal studies.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  08/H0717/86

• Date of REC Opinion

  25 Nov 2008

• REC opinion

  Favourable Opinion