Single & multiple inhaled doses of RPL554 in healthy males and in COPD

• Research type

  Research Study

• Full title

  A phase I, randomised, double blind, placebo-controlled, 3-part study to assess the safety, tolerability and pharmacokinetics of single and multiple inhaled doses of RPL554 administered by nebulizer to healthy male subjects and stable COPD subjects.

• IRAS ID

  160189

• Contact name

  Dave Singh

• Contact email

  dsingh@meu.org.uk

• Sponsor organisation

  Verona Pharma plc

• Eudract number

  2014-002916-17

• Research summary

  The study consists of a Single Ascending Dose (SAD) phase (Part A) and a Multiple Ascending Dose (MAD) phase (Part B) in healthy subjects and a MAD phase (Part C) in stable Chronic Obstructive Pulmonary Disease (COPD) subjects. In each part of the study (A, B and C) the aim is that each cohort should comprise 10 subjects: 7 on active, 3 on placebo. Dosing will take place over 6 days during the MAD phases of the study, three times-a-day on Days 1-5 and once-a-day on Day 6.

  The study is designed to assess the safety, tolerability and pharmacokinetic (PK) profile of RPL554 by inhalation via a nebuliser. The planned doses have been selected based on experience in previous studies utilising the solution formulation of RPL554. The decision on whether or not to escalate to each new dose level, and the dose, will be based on a formal review by the Dose Review Group (DRG).

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  14/LO/1512

• Date of REC Opinion

  24 Oct 2014

• REC opinion

  Further Information Favourable Opinion