Safety, tolerability and PK of RV1162 in healthy and COPD patients.

• Research type

  Research Study

• Full title

  A randomised, double blind, placebo-controlled, three part study to evaluate the safety, tolerability and pharmacokinetics of treatment with single and repeat doses of inhaled RV1162 in healthy subjects and subjects with Chronic Obstructive Pulmonary Disease.

• IRAS ID

  134858

• Contact name

  Dave Singh

• Contact email

  dsingh@meu.org.uk

• Sponsor organisation

  RespiVert Ltd

• Eudract number

  2013-002329-44

• Research summary

  RV1162 First in Human (FIH) - A randomised, double blind, placebo-controlled, three part study to evaluate the safety, tolerability and pharmacokinetics of treatment with single and repeat doses of inhaled RV1162 in healthy subjects and subjects with COPD.

  Study Drug: RV1162 is a new chemical entity with anti-inflammatory activity being developed for the treatment of chronic obstructive pulmonary disease (COPD) and asthma.

  This FIH study is designed to evaluate the safety, tolerability and pharmacokinetics (PK) of RV1162 when administered as both single and repeat doses. Demonstration of a well-tolerated formulation, with an acceptable safety profile, will support the progression of RV1162 for evaluation in subsequent clinical studies in subjects with COPD and asthma.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  13/NW/0499

• Date of REC Opinion

  2 Oct 2013

• REC opinion

  Further Information Favourable Opinion