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

Primary Purpose

Cystic Fibrosis

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

OligoG CF-5/20

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Digestive System Diseases, Genetic Diseases, Inborn, Respiratory Tract Diseases, Cystic Fibrosis, Lung Disease, Pancreatic Diseases

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inhaled OligoG CF-5/20

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00970346

First Posted

September 1, 2009

Last Updated

March 22, 2016

Sponsor

AlgiPharma AS

Collaborators

Smerud Medical Research International AS

1. Study Identification

Unique Protocol Identification Number

NCT00970346

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

September 2009 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AlgiPharma AS

Collaborators

Smerud Medical Research International AS

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cystic Fibrosis

Keywords

Digestive System Diseases, Genetic Diseases, Inborn, Respiratory Tract Diseases, Cystic Fibrosis, Lung Disease, Pancreatic Diseases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inhaled OligoG CF-5/20

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

OligoG CF-5/20

Intervention Description

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

Primary Outcome Measure Information:

Title

Time Frame

3 days dosing

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Salvatore Febbraro

Organizational Affiliation

Simbec Research

Official's Role

Principal Investigator

Facility Information:

City

Merthyr Tydfil

Country

United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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