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

AlgiPharma AS0 sites26 target enrollmentSeptember 2009

ConditionsCystic Fibrosis

InterventionsOligoG CF-5/20

DrugsOligoG CF-5/20

Overview

Phase: Phase 1
Intervention: OligoG CF-5/20
Conditions: Cystic Fibrosis
Sponsor: AlgiPharma AS
Enrollment: 26
Primary Endpoint: To determine the safety and local tolerability of multiple dose administration of inhaled alginate oligosaccharide (OligoG CF-5/20) fragment in healthy volunteers, particular emphasis will be put on pulmonary functioning and pulmonary adverse events.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

November 2009

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

AlgiPharma AS

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy, male subjects aged 18 to 65 years inclusive
•Normal pulmonary function; i.e. FEV1 ≥ 80% of predicted (for age, sex, height and race) and FEV1/FVC ratio ≥ 0.7
•Subject's pre -study physical examination, vital signs and electrocardiogram (ECG) are normal or do not show any clinically significant abnormalities as determined by the investigator
•Subject's pre - study laboratory screen are normal or, if outside of the laboratory reference range, not considered clinically significant

Exclusion Criteria

•History of any clinically relevant chronic respiratory disorder, including asthma
•Current smoker or smoked within the last 12 months
•History of significant drug or alcohol abuse (defined by the investigator). Subjects with a positive screen for alcohol or drugs of abuse at screening/admission will be excluded from participation in the study.
•Subject who has inhaled any drug in the last 30 days prior to Day 1
•Subject who has received one or more days of systemic pharmacological treatment in the 14 days immediately prior to Day 1
•Participation in a New Chemical Entity clinical study within the previous 16 weeks or a marketed drug clinical study within the previous 12 weeks
•Subjects with a clinically relevant history of significant hepatic, renal, endocrine, cardiac, nervous, psychiatric, gastrointestinal, pulmonary, haematological or metabolic disorder

Arms & Interventions

Inhaled OligoG CF-5/20

Intervention: OligoG CF-5/20

Outcomes

Primary Outcomes

To determine the safety and local tolerability of multiple dose administration of inhaled alginate oligosaccharide (OligoG CF-5/20) fragment in healthy volunteers, particular emphasis will be put on pulmonary functioning and pulmonary adverse events.

Time Frame: 3 days dosing