Safety, Tolerability and PK of Inhaled CHF 6001

• Research type

  Research Study

• Full title

  A phase I randomised, double-blind, placebo-controlled study of single and repeated ascending doses in healthy volunteers to investigate the safety, tolerability and pharmacokinetics of inhaled CHF 6001.

• IRAS ID

  162849

• Contact name

  Stuart Mair

• Contact email

  Stuart.Mair@quotientclinical.com

• Sponsor organisation

  Chiesi Farmaceutici S.p.A.

• Eudract number

  2014-002207-19

• Research summary

  The Sponsor is developing the study drug, CHF 6001, as a new potential treatment to reduce inflammation in patients with COPD (Chronic Obstructive Pulmonary Disease).

  The study will assess the safety and tolerability of single and repeated ascending doses of the study drug.

  The study will be split into 2 parts. Part 1 will consist of 1 cohort of up to 12 healthy male and female subjects, and part 2 will consist of 3 cohorts of up to 12 healthy male and female subjects in each cohort. Escalation to the next dose level (parts 1 and 2) will be decided on the basis of safety data originating from the previous dose. In Part 1, 9 subjects will be dosed once at each of 3 study visits with 3 ascending dose levels of the study drug, whilst 3 subjects will receive a placebo:

  • Dose 1 - Single dose of CHF 6001-Total dose 2400 µg or placebo
  • Dose 1 - Single dose of CHF 6001-Total dose 4000 µg or placebo
  • Dose 1 - Single dose of CHF 6001-Total dose 4800 µg or placebo

  In Part 2, 9 subjects in each cohort will be administered 3 multiple doses of the study drug for 14 days, and 3 will receive a placebo:
  
  •Dose 1 - Multiple doses of CHF 6001 - Total daily dose 2400 µg or placebo
  •Dose 2 - Multiple doses of CHF 6001 - Total daily dose 4000 µg or placebo
  •Dose 3 - Multiple doses of CHF 6001 - Total daily dose 4800 µg or placebo

• REC name

  Wales REC 1

• REC reference

  14/WA/1115

• Date of REC Opinion

  10 Sep 2014

• REC opinion

  Further Information Favourable Opinion