NCT01661244

A Study to Investigate the Safety and Tolerability of a New Inhaled Formulation of RV568 in Healthy Volunteers

A Randomised, Double-blind, Placebo-controlled, Two Part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Treatment With Single and Repeat Doses of Inhaled RV568 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Respivert Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

RV568 is being developed as a possible treatment of smoking related lung disease (also known as Chronic Obstructive Pulmonary Disease - COPD). The main purpose of this study is to examine the safety and tolerability of a new inhaled formulation of RV568 in healthy volunteers. The study will be run in two parts; Part A and Part B. Part A (Cohorts 1, 2 \& 3) will investigate 6 different dose levels of RV568 given as a single dose and Part B (Cohorts 4 \& 5) will investigate 2 different dose levels of RV568 given once a day for 14 days.

Conditions

• COPD
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	RV568 single dose	Safety and tolerability of single escalating doses in normal human volunteers
DRUG	RV568 matching placebo single dose	Safety and tolerability of escalating repeat doses in normal human volunteers.
DRUG	RV568 repeat dose	Safety and tolerability of escalating repeat doses in normal human volunteers.
DRUG	RV568 matching placebo repeat dose	Safety and tolerability of escalating repeat doses in normal human volunteers.

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2012-08-09
• Last updated: 2013-03-04

Locations

1 site across 1 country: United Kingdom