RV568 is being developed as a possible treatment of smoking related lung disease (also known as Chronic Obstructive Pulmonary Disease - COPD). The main purpose of this study is to examine the safety and tolerability of a new inhaled formulation of RV568 in healthy volunteers. The study will be run in two parts; Part A and Part B. Part A (Cohorts 1, 2 \& 3) will investigate 6 different dose levels of RV568 given as a single dose and Part B (Cohorts 4 \& 5) will investigate 2 different dose levels of RV568 given once a day for 14 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Safety and tolerability of single escalating doses in normal human volunteers
Safety and tolerability of escalating repeat doses in normal human volunteers.
Safety and tolerability of escalating repeat doses in normal human volunteers.
Safety and tolerability of escalating repeat doses in normal human volunteers.
Unnamed facility
London, United Kingdom
Incidence of treatment emergent adverse events
Assessment of the number of adverse events reported by subjects following dosing.
Time frame: Cohort 1, 56 days; Cohorts 2 & 3, 28 days; Cohorts 4 & 5, 35 days
ECG assessment
Change from pre-dose values.
Time frame: Cohort 1, 56 days; Cohorts 2 & 3, 28 days; Cohorts 4 & 5, 35 days
Vital signs assessment
Change from pre-dose values
Time frame: Cohort 1, 56 days; Cohorts 2 & 3, 28 days; Cohorts 4 & 5, 35 days
Spirometry assessment
Change from pre-dose values
Time frame: Cohort 1, 56 days; Cohorts 2 & 3, 28 days; Cohorts 4 & 5, 35 days
Plasma RV568 levels
Time frame: Cohorts 1, 2 & 3: Day 1 (0, 15, 30 & 45 min and 1, 2, 4, 6, 8, 10, 12 and 24 h), then 7, 14 and 28 days. Cohorts 4 & 5: Day 1, 7 & 14 (0, 15, 30 & 45 min and 1, 2, 4, 6, 8, 10, 12 and 24 h), Day 10, 11, 12 & 13 (0 & 30 min), then Day 21, 28 and 35
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