Status and phase
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About
This single and repeat increasing dose study will collect information on safety, tolerability and drug levels in the body of the CCI15106 inhalation powder. The study will also look at the level of CCI15106 that will be released into the air and may be found in the blood of the people standing around the person inhaling it (bystanders). This is a two-part study in which Part 1 will enroll healthy subjects and look at environmental and bystander exposure and Part 2 will enroll subjects with moderate COPD. Approximately 36 healthy subjects and approximately 22 subjects with COPD will be randomized in this study for dosing. The total study duration will be 82 days for Cohort A Part 1; 75 days for Cohort B Part 1 and Cohort C Part 1; 77 days for Cohort A Part 2; and 90 days for Cohort B Part 2.
Enrollment
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Inclusion and exclusion criteria
Some important Inclusion Criteria:
For healthy subjects and bystanders:
For subjects with COPD:
Some Important Exclusion Criteria:
For healthy subjects and bystanders:
For subjects with COPD:
Primary purpose
Allocation
Interventional model
Masking
52 participants in 9 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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