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

NCT00970346 | Completed Phase 1

• 1 other identifier: SMR-1916
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Inhaled OligoG CF-5/20

EXPERIMENTAL

Drug: OligoG CF-5/20

Interventions

OligoG CF-5/20 DRUG

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

Inhaled OligoG CF-5/20

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AlgiPharma AS: lead
• Smerud Medical Research International AS: collaborator

Study Sites (1)

Unknown Facility

Merthyr Tydfil, United Kingdom

Location

MeSH Terms

Conditions

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

Interventions

oligoG CF-5-20

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Salvatore Febbraro

  Simbec Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2009
• First Posted: September 2, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 23, 2016

Record last verified: 2016-03

Locations

GB (1)