Study investigating the safety, tolerability, pharmacokinetics and early efficacy with KIT2014 over 7 days of treatment in moderate to severe chronic obstructive pulmonary disease patients.
This is a Multicentre, Randomised, Double-Blind, Placebo-Controlled, Dose Ranging, Phase 1b/2a Study to Investigate the Safety, Tolerability, Pharmacokinetics and Early Efficacy of Inhaled KIT2014 Over 7 Days of Treatment in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease. The study will be conducted in 3 ascending dose cohorts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
36
Novatrials
Charlestown, New South Wales, Australia
RECRUITINGEmeritus Research
Camberwell, Victoria, Australia
RECRUITINGTreatment-emergent adverse events(TEAEs),serious adverse events(SAEs)
Incidence, type, severity, and relationship of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and TEAEs leading to discontinuation of study treatment.
Time frame: From first dose to post-treatment follow up visit on Day 9.
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