This is a first in human study of ETD002 a new drug being developed for the treatment of cystic fibrosis.The study is a randomised, double-blind, placebo-controlled, interventional study to assess the safety and tolerability of ascending single and repeat doses of inhaled ETD002 in healthy male and female subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Single ascending doses of ETD002
Single doses of placebo
Twice daily doses of ETD002 for 7 days
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 safety 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 ETD002
Blood levels of ETD002 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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Twice daily doses of Placebo for 7 days
Twice daily doses of ETD002 for 14 days
Twice daily doses of Placebo for 14 days
Twice daily doses of salbutamol for 3 days (Days 5, 6 \& 7)