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

Cystic Fibrosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970346
• Other study ID #: SMR-1916
• Status: Completed
• Phase: Phase 1
• First received: September 1, 2009
• Last updated: March 22, 2016
• Start date: September 2009
• Est. completion date: November 2009

Study information

• Verified date: March 2016
• Source: AlgiPharma AS
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
AlgiPharma AS	Smerud Medical Research International AS

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		3 days dosing	Yes