NCT00970346

Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic Fibrosis

A Randomised, Double-blind, Placebo-controlled Dose-escalation Phase I Study to Evaluate the Safety and Tolerability of Inhaled Aerosolised OligoG CF-5/20 (G-block Oligosaccharide Derived From Alginate Polysaccharide) in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: AlgiPharma AS · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Cystic fibrosis (CF) is a disease caused by a mutation in the gene that makes the cystic fibrosis transmembrane regulator protein. As a result mucus stagnation, obstruction and plugging take place in the respiratory and gastrointestinal tract, the biliary and pancreatic duct, and in the reproductive system. The objective of this study is to determine the safety and tolerability of 3 days of daily dosing of OligoG CF-5/20 versus placebo in healthy volunteers.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	OligoG CF-5/20	Inhaled OligoG CF-5/20 will be given to healthy volunteers with different concentrations to test tolerability of the drug

Timeline

• Start date: 2009-09-01
• Primary completion: 2009-10-01
• Completion: 2009-11-01
• First posted: 2009-09-02
• Last updated: 2016-03-23

Locations

1 site across 1 country: United Kingdom