This is a first in human study of ETD001 a new drug being developed for the treatment of cystic fibrosis. The study is a randomised, placebo-controlled, double-blind interventional study to assess the safety, tolerability and pharmacokinetics of single and multiple ascending doses of inhaled ETD001in healthy male and female subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
98
Single ascending doses of inhaled ETD001
Single doses of inhaled placebo
Ascending doses of inhaled ETD001 administered twice daily
Hammersmith Medicines Research
London, United Kingdom
Number of participants reporting one or more treatment emergent adverse event (TEAE)
Time frame: Baseline to Week 8
Number of participants who discontinue due to an adverse event (AE)
Time frame: Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for 12-lead ECG assessment at least once post dose
Time frame: Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for vital signs assessments at least once post dose
Time frame: Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for laboratory assessments at least once post dose
Time frame: Baseline to Week 8
Number of participants who meet the markedly abnormal criteria for spirometry assessments at least once post dose
Time frame: Baseline to Week 8
Plasma concentrations of ETD001
Blood levels of ETD001 measured after dosing
Time frame: Day 1 pre-dose and at multiple time-points (up to 14 days) post final dose
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Doses of inhaled placebo administered twice daily
Doses of inhaled ETD001 administered once daily
Doses of inhaled placebo administered once daily