Phase 1 Study to Assess Rectal Brilacidin Dosages (QSC203196)

• Research type

  Research Study

• Full title

  A Randomised, Phase 1 Study to Assess Safety, Tolerability, Retention, Product Acceptability, and Pharmacokinetics of Different Dosages of Rectal Enema Formulation of Brilacidin in Healthy Volunteers

• IRAS ID

  285215

• Contact name

  Giulia Bruno

• Contact email

  giulia.bruno@alfasigma.com

• Sponsor organisation

  Alfasigma S.p.A.

• Eudract number

  2020-001297-29

• Duration of Study in the UK

  0 years, 1 months, 26 days

• Research summary

  Research Summary
  The Sponsor is developing the test medicine, Brilacidin, for the potential treatment of inflammatory bowel conditions such as ulcerative proctitis and ulcerative proctosigmoiditis. The conditions are both forms of ulcerative colitis, a long-term condition where the colon and rectum become inflamed. It is thought that these conditions are caused by the immune system wrongly attacking the body’s own cells. The test medicine has anti-bacterial and anti-inflammatory properties that should help reduce the symptoms of these conditions. The test medicine will be administered in the form of an enema, which is a liquid medicine given via the rectum (back passage). \n\nThe study will try to provide safety and tolerability information for the test medicine when given rectally for seven days. It will also assess how much of the test medicine enters the bloodstream over time (pharmacokinetics) and provide additional information on the retention time and product acceptability of the formulation. \n\nThe study will consist of three study cohorts involving up to 24 healthy male and female volunteers (of non-childbearing potential). In each cohort, up to eight volunteers will receive a dose of the test medicine or matching placebo, once daily for seven days. Each cohort will receive a different dose of the test medicine; 50 mg, 200 mg or 400 mg. Volunteers will be admitted to the clinical unit on Day -1 (day before dosing) and remain resident in the clinic until Day 10, with dosing on Day 1 to Day 7. There will be a follow-up visit on Day 15 for safety assessments.

  Summary of Results
  Given that this is a phase 1 trial, no lay summary of results has been provided for reasons of commercial confidentiality

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  20/LO/1065

• Date of REC Opinion

  26 Oct 2020

• REC opinion

  Further Information Favourable Opinion