Study of CHF6366 in healthy subjects and patients with Asthma and COPD

• Research type

  Research Study

• Full title

  A First in Human Randomised, Double-Blind, Placebo-Controlled Study of Single Ascending Doses in Healthy Male Volunteers and Repeated Ascending Dose in Asthmatic Patients Followed by a 3-Way Cross-Over, Placebo-Controlled, Single-Dose in COPD Patients to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CHF6366

• IRAS ID

  224770

• Contact name

  Ilaria Panni

• Contact email

  i.panni@chiesi.com

• Sponsor organisation

  Chiesi Farmaceutici

• Eudract number

  2015-005551-27

• Duration of Study in the UK

  0 years, 10 months, 12 days

• Research summary

  CHF 6366 is a new chemical entity developed to treat patients with Asthma and COPD, the study is designed to see how safe and how well tolerated the drug is in healthy volunteers and the target patient population.

  The study will consist of three parts:
  Part 1
  The investigational drug, or placebo, will be given at increasing dose levels of single doses in healthy male volunteers. Volunteers will be dosed over 3 periods separated by 14 days.

  Part 2
  Multiple doses of increasing strength CHF 6366 or placebo will be given over 7 days to patients with mild asthma.

  Part 3
  Males with COPD will be dosed with a single dose of CHF 6366, placebo and comparator drug over 3 periods.

  All subjects will undergo safety evaluations whilst on study to include blood pressure, ECGs, laboratory testing, physical examinations and ongoing surveillance for adverse events whilst resident and at out-patients visits where applicable.
  Samples will also be collected for measuring levels of CHF 6366 and metabolites in blood, urine and faeces.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  17/LO/1811

• Date of REC Opinion

  11 Dec 2017

• REC opinion

  Further Information Favourable Opinion