Safety, PK, and PD of RV1729 in patients with COPD

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety, pharmacokinetics and pharmacodynamics of inhaled RV1729 in patients with COPD.

• IRAS ID

  151704

• Contact name

  Dave Singh

• Contact email

  dsingh@meu.org.uk

• Sponsor organisation

  RespiVert Ltd

• Eudract number

  2014-000089-23

• Research summary

  This is a randomised, double-blind, placebo-controlled, parallel-group, multi-centre Phase 1b study to evaluate the safety, tolerability and pharmacokinetic profile of inhaled RV1729 administered as a dry powder, once daily for 28 days, in subjects with moderate to severe, stable COPD.

  Study Drug: RV1729 is a new chemical entity with anti-inflammatory activity being developed for the treatment of chronic obstructive pulmonary disease (COPD) and uncontrolled asthma.

  The study will be conducted in a multi-centre setting and comprises a Screening period of up to 28 days, a 28-day treatment period and a 28-day follow-up period. Subjects will be dosed daily at the clinical research unit (CRU) throughout Days 1–15. Thereafter, dosing may occur at home on days when a visit to the CRU is not required for additional procedures to be performed. Alternatively if the CRU prefers subjects may attend the CRU daily for dosing throughout Days 1–28.

• REC name

  North West - Greater Manchester South Research Ethics Committee

• REC reference

  14/NW/0198

• Date of REC Opinion

  14 May 2014

• REC opinion

  Further Information Favourable Opinion