A Phase 1 study of Multiple Ascending Doses of PBI-4050

• Research type

  Research Study

• Full title

  A Phase 1, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, tolerability and Pharmacokinetics of Multiple Ascending Doses of PBI-4050 in Healthy Subjects

• IRAS ID

  290077

• Contact name

  Firas Almazedi

• Contact email

  firas.almazedi@covance.com

• Sponsor organisation

  Liminal BioSciences Ltd.

• Eudract number

  2020-003504-14

• Clinicaltrials.gov Identifier

  20/WA/0289, REC Ref

• Duration of Study in the UK

  0 years, 5 months, 12 days

• Research summary

  Summary of Research
  PBI-4050 is being developed for use in the future with diseases associated with fibrosis (a condition where tissues in the body scar and stiffen, causing permanent damage) and inflammation.

  The purpose of this study is to investigate the study drug PBI-4050 to determine the safety, tolerability and concentration profile in the blood when the drug is given as multiple doses over a period of 14 days, and the aims are as follows:

  • The safety of the Study Drug and any side effects that might be associated with it,
  • How much of the Study Drug and its breakdown products get into the bloodstream,
  • How quickly the Study Drug and its breakdown products leaves the bloodstream.

  This study will contain 6 groups, with varying doses as outlined in A13. Each group will comprise of 12 participants; 9 who will receive the active drug PBI-4050 and 3 who will receive a placebo (containing no active drug). In this study, PBI-4050 will be given in the form of an oral softgel capsule (multiple capsules per dose).

  Cohort A will include dosing once daily, whereas Cohorts B to D will receive the study drug twice daily. Cohort F has been included as female subjects will be enrolled across all cohorts, however should a sufficient number of females subjects not be enrolled, an assessment will be made to determine the minimum number of female subjects required to complete the study in this cohort.
  
  Summary of Results
  A lay summary of the results is not available

• REC name

  Wales REC 1

• REC reference

  20/WA/0289

• Date of REC Opinion

  18 Nov 2020

• REC opinion

  Further Information Favourable Opinion