A Randomised, SAD/MAD Study to Assess Safety & PK of DS102

• Research type

  Research Study

• Full title

  A Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Dose Phase I Study to Assess the Safety, Pharmcokinetics and Effect of Food on Orally Administered DS102 in Healthy Subjects.

• IRAS ID

  179905

• Contact name

  John Climax

• Sponsor organisation

  Dignity Sciences Ltd

• Eudract number

  2015-001153-33

• Duration of Study in the UK

  0 years, 2 months, 11 days

• Research summary

  DS102 is the endogenously occurring essential fatty acid 15-Hydroxy-Eicosapentaenoic Acid Ethyl Ester (15-HEPE EE), the 15-Lipoxygenase metabolite of Eicosapentaenoic Acid (EPA). EPA exerts its therapeutic effects by competing with arachidonic acid (AA) for metabolism by the cyclooxygenase and lipoxygenase pathways reducing inflammation.

  In the human body, the exact conversion rate of EPA to 15-HEPE is unknown but it has been illustrated in platelets that EPA converts into 15-HEPE.15-HEPE has also been shown in the literature to have anti-inflammatory properties and for the first time has shown novel antibacterial properties against S. aureus.

  DS102 has been shown to have significant effects on both the NAFLD activity score and fibrosis in a murine model of non-alcoholic steatohepatitis. Dignity Sciences are investigating the potential clinical utility of DS102 in liver disease and fibrosis preclinically.

  There will be 2 parts to the study. Part 1 will evaluate the relevant safety data for four dose levels. Initially three dose levels (100mg, 500mg and 1000mg) wil be administered and the safety data from the 1000mg dose level evaluated before moving to the fourth dose level, 2000mg.

  Part 2, the multiple dose regime, will begin in parallel with the 2000mg single dose cohort, again only when the safety data of the 1000mg dose level has been evaluated. Part 2 will begin at 500mg/day increasing to a cohort who will be dosed at 1000mg/day for a total of 28 days.

• REC name

  South Central - Berkshire B Research Ethics Committee

• REC reference

  15/SC/0221

• Date of REC Opinion

  1 Jun 2015

• REC opinion

  Further Information Favourable Opinion