SNF472 SAD & MAD in healthies, SAD in haemodialysis patients

• Research type

  Research Study

• Full title

  A First Time in Human, Double Blind, Randomised, Placebo Controlled Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Intravenous Doses of SNF472 in Healthy Male Volunteers, and a Single Intravenous Dose of SNF472 in Male Haemodialysis Patients

• IRAS ID

  146640

• Sponsor organisation

  Laboratoris Sanifit

• Eudract number

  2013-005125-23

• ISRCTN Number

  xx

• Clinicaltrials.gov Identifier

  xx

• Research summary

  The new medicine tested in this study is a compound called SNF472.

  Laboratoris Sanifit is developing the study drug for the prevention of the progression of cardiovascular calcification (CVC) (deposition of calcium into the blood vessel structures of the heart) in patients with end stage renal (kidney) disease (ESRD) undergoing haemodialysis (a method that is used to remove waste products from the blood when the kidneys are failing) and for calciphylaxis (syndrome of vascular calcification) patients.

  SNF472 is composed by a naturally occurring substance (IP6) found in beans, brown rice, corn, sesame seeds, wheat bran and other high fibre foods. The calcium salt of IP6 is listed by the Food and Drug Administration (FDA) and is generally recognised as safe. Beneficial properties have been attributed to IP6 in oncology and calcium related diseases (e.g., prevention of renal lithiasis [Kidney stones], osteoporosis [a progressive bone disease], CVC, sialolithiasis [salivary stones] and dental tartar). So, humans are exposed continuously to IP6 as it comes from diet. SNF472 is the intravenous formulation of IP6, so higher exposures than physiological (from diet) will be reached

  The main purpose of the study is to see how safe the study drug is and how well it is tolerated after dosing. The study will also investigate how the study drug is taken up, metabolised (chemically broken down), distributed through the body and excreted.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  14/LO/0102

• Date of REC Opinion

  31 Jan 2014

• REC opinion

  Favourable Opinion