Status:
COMPLETED
Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic Fibrosis
Lead Sponsor:
AlgiPharma AS
Collaborating Sponsors:
Smerud Medical Research International AS
Conditions:
Cystic Fibrosis
Eligibility:
MALE
18-65 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT00970346
Start Date
September 1 2009
End Date
November 1 2009
Last Update
March 23 2016
Active Locations (1)
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1
Merthyr Tydfil, United Kingdom