KIT2014 in COPD: safety, tolerability, and early efficacy in moderate to severe COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and early efficacy of inhaled KIT2014 in adults with moderate to severe COPD. The trial uses three ascending dose cohorts in a phase 1b/2a framework to characterize how the drug behaves in the body and any initial clinical effects over a one-week treatment period. Participants are adults aged 40–80 with a ≥12-month history of COPD and a documented 40–80% post-bronchodilator FEV1, who are current or former smokers. Key outcomes include adverse events, PK parameters, and early improvements in COPD-related symptoms and lung function. The study is conducted at multiple centers with a placebo control to enable clear assessment of KIT2014’s safety and potential early efficacy signals.

Why it matters

Who can join: the full rules

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.

Where it's running

• Novatrials
  Charlestown, New South Wales, Australia Recruiting
• Emeritus Research
  Camberwell, Victoria, Australia Recruiting
• Emeritus Research Sydney
  Sydney, New South Wales, Australia Not yet recruiting

Study contacts

• Principal investigator: Alexander Gordon, MBBS FRACP — Novatrials
• Study coordinator: Katrina Asher
• Email: katrina@novatrials.com.au
• Phone: +61 2 4058 5477

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.