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

NCT01661244 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2013-03-04

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Respivert Ltd

    lead INDUSTRY

Principal Investigators

  • Dr Garth Rapeport · Respivert Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-09-30
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01661244 on ClinicalTrials.gov