A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD001 in Healthy Subjects
NCT ID: NCT04926701
Last Updated: 2022-03-24
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
98 participants
INTERVENTIONAL
2021-06-11
2022-03-22
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Single ascending dose
Single dose of inhaled ETD001/placebo on one occasion
ETD001 single dose
Single ascending doses of inhaled ETD001
Placebo single dose
Single doses of inhaled placebo
Multiple ascending dose (7 days)
Daily doses of ETD001/placebo for 7 consecutive days
ETD001 multiple twice daily doses
Ascending doses of inhaled ETD001 administered twice daily
Placebo multiple twice daily doses
Doses of inhaled placebo administered twice daily
ETD001 multiple once daily doses
Doses of inhaled ETD001 administered once daily
Placebo multiple once daily doses
Doses of inhaled placebo administered once daily
Multiple ascending dose (14 days)
Daily doses of ETD001/placebo for 14 consecutive days
ETD001 multiple twice daily doses
Ascending doses of inhaled ETD001 administered twice daily
Placebo multiple twice daily doses
Doses of inhaled placebo administered twice daily
Interventions
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ETD001 single dose
Single ascending doses of inhaled ETD001
Placebo single dose
Single doses of inhaled placebo
ETD001 multiple twice daily doses
Ascending doses of inhaled ETD001 administered twice daily
Placebo multiple twice daily doses
Doses of inhaled placebo administered twice daily
ETD001 multiple once daily doses
Doses of inhaled ETD001 administered once daily
Placebo multiple once daily doses
Doses of inhaled placebo administered once daily
Eligibility Criteria
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Inclusion Criteria
* Consent to study participation
* Body weight ≥ 50 kg and body mass index 19 - 30 kg/m2
* Vital sign assessments within the normal ranges
* Healthy as determined following physical and laboratory examinations at screening visit
* Spirometry readings (FEV1 and FVC) to be ≥ 80% of predicted value
Exclusion Criteria
* Respiratory tract infection within 4 weeks of the screening visit
* Use of prescribed or OTC medication within 14 days of the screening visit
* History of regular alcohol use over the recommended limits within 6 months of screening, or history/evidence of alcohol or drug abuse
* Smoker or use of tobacco products within 6 months of screening
* Abnormal blood or urine laboratory test results at screening
* Recent participation (within 3 months) in another clinical trial
* Current, or history of, allergy that may be contraindicated
18 Years
50 Years
ALL
Yes
Sponsors
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Enterprise Therapeutics Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Niyati Prasad, MD
Role: STUDY_DIRECTOR
Enterprise Therapeutics
Locations
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Hammersmith Medicines Research
London, , United Kingdom
Countries
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Other Identifiers
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ET-ENAC-01
Identifier Type: -
Identifier Source: org_study_id
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