A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD002 in Healthy Subjects
NCT ID: NCT04488705
Last Updated: 2021-05-21
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
80 participants
INTERVENTIONAL
2020-08-13
2021-05-19
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
ETD002 - single dose
Single ascending doses of ETD002
Placebo - single dose
Single doses of placebo
Repeat dose - 7 days
ETD002 - 7 day repeat dose
Twice daily doses of ETD002 for 7 days
Placebo - 7 day repeat dose
Twice daily doses of Placebo for 7 days
Repeat dose - 14 days
ETD002 - 14 day repeat dose
Twice daily doses of ETD002 for 14 days
Placebo - 14 day repeat dose
Twice daily doses of Placebo for 14 days
Repeat dose - 7 days with SABA
ETD002 - 7 day repeat dose
Twice daily doses of ETD002 for 7 days
Placebo - 7 day repeat dose
Twice daily doses of Placebo for 7 days
Salbutamol
Twice daily doses of salbutamol for 3 days (Days 5, 6 \& 7)
Interventions
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ETD002 - single dose
Single ascending doses of ETD002
Placebo - single dose
Single doses of placebo
ETD002 - 7 day repeat dose
Twice daily doses of ETD002 for 7 days
Placebo - 7 day repeat dose
Twice daily doses of Placebo for 7 days
ETD002 - 14 day repeat dose
Twice daily doses of ETD002 for 14 days
Placebo - 14 day repeat dose
Twice daily doses of Placebo for 14 days
Salbutamol
Twice daily doses of salbutamol for 3 days (Days 5, 6 \& 7)
Eligibility Criteria
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Inclusion Criteria
* Consent to study participation
* Body weight ≥ 50 kg and body mass index within the range 19 - 30 kg/m2
* Vital signs assessments within normal ranges
* Healthy as determined following physical examination 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 prescription or OTC medication within 14 days of the screening visit
* History of regular alcohol consumption over recommended limits within 6 months of the study, or history/evidence of alcohol or drug abuse
* Smoking or use of tobacco products within 6 months of screening
* Abnormal blood/urine laboratory screening test results
* 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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David Morris, 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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2020-001080-92
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ET-TMEM-01
Identifier Type: -
Identifier Source: org_study_id
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