NCT01921712

A Safety, Pharmacokinetic and Pharmacodynamic Study of PUR0200 in COPD Patients

A Phase I, 2-Part, Single-dose, Placebo and Active-Controlled, Dose-ranging, Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety and Tolerability in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Pulmatrix Inc. · Industry
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and tolerability of PUR0200. In addition, the study will look at the blood levels of different doses of PUR0200 and their affect on lung function in COPD patients.

Detailed description

This is a multi-center, 2-part, pharmacokinetic (PK), pharmacodynamic (PD) effect, safety and tolerability study of single doses of PUR0200.

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	PUR0200	Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator
DRUG	PUR0200 Placebo	Randomized, single dose of inhaled placebo matched to PUR0200
DRUG	Active comparator	Randomized single dose of inhaled active comparator product

Timeline

• Start date: 2013-07-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-08-13
• Last updated: 2014-03-18

Locations

2 sites across 1 country: United Kingdom