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Clinical Trials in Australia / NCT07668518
Recruiting Phase 1/2

A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of KIT2014 in Patients With Moderate to Severe COPD

NCT07668518 · tracked via the Priya Life Science Australia tracker
Sponsor
Kither Biotech Srl
Phase
Phase 1/2
Started
2026-08-05
Last updated
2026-09-09

Condition(s) studied

Chronic Obstructive Pulmonary Disease (COPD)

Investigational drug(s) / intervention(s)

KIT2014Placebo

KIT2014: KIT2014 will be administered by inhalation with a nebuliser

Placebo: Placebo will be administered by inhalation with a nebuliser

Study summary

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

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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. * FEV1 post-bronchodilator of 40% to 80% of predicted normal at Screening * Current symptoms of COPD, including bronchitis and/or dyspnoea on moderate exertion at screening. Exclusion Criteria: * 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). Other inclusion/exclusion eligibility criteria apply.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Novatrials Charlestown New South Wales Recruiting
Emeritus Research Camberwell Victoria Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07668518 on ClinicalTrials.gov ↗ ← All trials in Australia