MedTrace Logo

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

NCT00970346 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2016-03-23

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Smerud Medical Research International AS

    collaborator OTHER

  • AlgiPharma AS

    lead INDUSTRY

Principal Investigators

  • Salvatore Febbraro · Simbec Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2009-10-31
Completion
2009-11-30

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 NCT00970346 on ClinicalTrials.gov