A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects
NCT ID: NCT03056326
Last Updated: 2017-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
72 participants
INTERVENTIONAL
2016-11-30
2017-07-31
Brief Summary
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The study will comprise two parts:
Part 1 will consist of two alternated cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6333.
Part 2 will consist of four sequential cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6333
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
TREATMENT
QUADRUPLE
Study Groups
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CHF6333 Active
CHF6333 (Part 1 - SAD)
Single doses of CHF6333 at each period
CHF6333 (Part 2 - MAD)
once daily multiple doses of CHF6333 for 14 days
Placebo
Placebo (Part 1 - SAD)
Single doses of placebo matching CHF6333 at each period
Placebo (Part 2 - MAD)
once daily multiple doses of placebo matching CHF6333 for 14 days
Interventions
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CHF6333 (Part 1 - SAD)
Single doses of CHF6333 at each period
Placebo (Part 1 - SAD)
Single doses of placebo matching CHF6333 at each period
CHF6333 (Part 2 - MAD)
once daily multiple doses of CHF6333 for 14 days
Placebo (Part 2 - MAD)
once daily multiple doses of placebo matching CHF6333 for 14 days
Eligibility Criteria
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Inclusion Criteria
* BMI between 18-30 kg/m2
* Non smokers
* Lung function above 80% of predicted normal value
* Healthy subjects based on medical evaluation including medical history, physical examination, laboratory tests and cardiac testing
Exclusion Criteria
* Abnormal laboratory values
* Recent respiratory tract infection
* Hypersensitivity to the drug or excipients
* Positive serology results
* Positive cotinine, alcohol, drug of abuse tests
* Unsuitable veins for repeated venepuncture
18 Years
55 Years
MALE
Yes
Sponsors
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Chiesi Farmaceutici S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Frédéric Vanhoutte
Role: PRINCIPAL_INVESTIGATOR
SGS Life Sciences, a division of SGS Belgium NV
Locations
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SGS Life Sciences
Antwerp, , Belgium
Countries
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Other Identifiers
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2015-005552-94
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CCD-06333AA1-01
Identifier Type: -
Identifier Source: org_study_id