NCT07668518 A Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of KIT2014 in Patients With Moderate to Severe COPD
| NCT ID | NCT07668518 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Kither Biotech Srl |
| Condition | Chronic Obstructive Pulmonary Disease (COPD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2026-08-05 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 36 participants in total. It began in 2026-08-05 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Alexander Gordon, MBBS FRACP
PRINCIPAL INVESTIGATOR
Novatrials
Frequently Asked Questions
Who can join the NCT07668518 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Chronic Obstructive Pulmonary Disease (COPD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07668518 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07668518 currently recruiting?
Yes, NCT07668518 is actively recruiting participants. Contact the research team at katrina@novatrials.com.au for enrollment information.
Where is the NCT07668518 trial being conducted?
This trial is being conducted at Charlestown, Australia, Sydney, Australia, Camberwell, Australia.
Who is sponsoring the NCT07668518 clinical trial?
NCT07668518 is sponsored by Kither Biotech Srl. The principal investigator is Alexander Gordon, MBBS FRACP at Novatrials. The trial plans to enroll 36 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.