NCT02517359

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Repeat Doses of RV6153

A Randomized, Double Blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Treatment With Single and Repeat Doses of Inhaled RV6153 in Healthy Subjects and Subjects With Stable Asthma.

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Respivert Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

RV6153 is a new medicine being developed for possible treatment of asthma and smoking related lung disease (also known as chronic obstructive pulmonary disease - COPD). The main purpose of this study is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of RV6153

Conditions

• Asthma
• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	RV6153 single dose	Safety and tolerability of single doses
DRUG	RV6153 matching placebo single dose	Safety and tolerability of single doses
DRUG	RV6153 14 day repeat dose	Safety and tolerability of repeat doses
DRUG	RV6153 matching placebo 14 day repeat dose	Safety and tolerability of repeat doses
DRUG	RV6153 28 day repeat dose	Safety and tolerability of repeat doses
DRUG	RV6153 matching placebo 28 day repeat dose	Safety and tolerability of repeat doses

Timeline

• Start date: 2015-07-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-08-07
• Last updated: 2016-03-04

Locations

2 sites across 1 country: United Kingdom