A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of KIT2014 in Patients With Moderate to Severe COPD
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorKither Biotech Srl
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must have given written informed consent before any study-related activities are performed and must be able to understand the full nature and purpose of the study, including possible risks and adverse effects
Adult males and females, 40 to 80 years of age (inclusive) at screening.
Current or former cigarette smokers with a ≥10 pack-year smoking history
Established physician diagnosis of COPD with associated symptoms defined by the GOLD guidelines for ≥ 12 months of screening.
Disqualifiers
History of life-threatening COPD
Chronic obstructive pulmonary disease exacerbation requiring oral or parenteral corticosteroids or hospitalisation within 3 months of Screening
Other clinically active, physician diagnosed moderate to severe respiratory disorders that could interfere with study assessments or confound results (e.g., asthma, bronchiectasis, pulmonary fibrosis, interstitial lung diseases, bronchiolitis obliterans, lung cancer, cor pulmonale, pulmonary hypertension, uncontrolled sleep apnoea, active tuberculosis).
Trial design
Design model
Sequential
Treatments tested in this trial
KIT2014
DrugKIT2014 will be administered by inhalation with a nebuliser
Placebo
DrugPlacebo will be administered by inhalation with a nebuliser
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: KIT2014Experimental treatment 1 intervention
Group B: PlaceboExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment-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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kither Biotech Srl
Lead sponsor
Avance Clinical Pty Ltd.
Collaborator
Source ClinicalTrials.gov