NCT07668518RecruitingPhase 1/2
A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of KIT2014 in Patients With Moderate to Severe COPD
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
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 19 Jun 2026
- Start date
- 5 Aug 2026
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Kither Biotech Srl
- Diseases
- COPD
- NCT number
- NCT07668518
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 36
- From 5 Aug 2026 to the primary completion date, 31 Mar 2027
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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.
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emeritus Research Coordinator of this site? Confirm its status | Camberwell | Australia | Recruiting |
| Novatrials Coordinator of this site? Confirm its status | Charlestown | Australia | Recruiting |
| Emeritus Research Sydney Coordinator of this site? Confirm its status | Sydney | Australia | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.